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MDSS-UK RP LIMITED

Authorized Representative in the United Kingdom

6 Wilmslow Road, Rusholme

Manchester, England, United Kingdom

Postcode: M14 5TP

Relationship Type: UK Responsible Person
1525 Products Represented
194 Manufacturers
Total Products
1525
Manufacturers
194
Device Types
4
Generic Names
953
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1525)
Complete portfolio registered with MHRA

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Manufacturer:

Diagnostic Hybrids, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose calliper, metallic

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose curette

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical sponge

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mouth gag support, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal speculum, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic chisel blade

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration hood, adult

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-coring punch, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue surgical hook, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Titanium dental bur

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone file/rasp, manual, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Advance Medical Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental computed radiography digital imaging scanner

Manufacturer:

Air Techniques, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient-monitoring bed mattress cover

Manufacturer:

Alimed Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic monitor

Manufacturer:

WR Medical Electronics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental precision attachment fitting/adjustment tool

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal/ENT/orthopaedic surgical probe, reusable

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic bender, reusable

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, internal

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, internal

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental digital imaging sensor, intraoral

Manufacturer:

ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLOGICA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

Aptos LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye anterior segment analyser

Manufacturer:

ArcScan, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cruciate-retaining total knee prosthesis

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyethylene patella prosthesis

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-stabilized total knee prosthesis

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total knee prosthesis implantation guide-instrument kit

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uncoated knee femur prosthesis, metallic

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Creagh Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal intense therapeutic ultrasound system handpiece

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy ultrasound system

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic orthopaedic extracorporeal shock wave therapy system

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

ECA Medical Instruments

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Migraine-therapy peripheral nerve electrical stimulator

Manufacturer:

ElectroCore, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hazardous chemical decontamination agent, professional

Manufacturer:

Emergent Protective Products USA Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic spirometer, professional

Manufacturer:

Pulmonx Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endobronchial valve

Manufacturer:

Pulmonx Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical/ultrasonic surgical system generator

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic motorized cutting stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic motorized cutting stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraluminal circular stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery manual linear stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system holder/tip, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system generator

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system generator

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tuberculin/allergy syringe/needle, safety

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, adult, single-use

Manufacturer:

CU Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physiologic-monitoring defibrillation system

Manufacturer:

CU Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological frequency-doubled solid-state laser system

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological laser beam guiding handpiece

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Light-energy skin surface treatment system applicator

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality skin contouring system applicator, infrared light

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system applicator, monopolar

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

Interrad Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Synaptive Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal irrigation set, home-use

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal mucosa dressing, non-antimicrobial

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-antimicrobial wound irrigation solution, saline

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid localized thermal/compression therapy system control unit

Manufacturer:

NICE Recovery Systems, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Manufacturer:

Tandem Diabetes Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, reusable

Manufacturer:

Temrex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

Temrex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Promega Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alternating electric field antimitotic cancer treatment system transducer array

Manufacturer:

Novocure GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Benchtop nebulizer, non-heated

Manufacturer:

HCMed Innovations Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing mouthpiece, reusable

Manufacturer:

HCMed Innovations Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy mask, aerosol

Manufacturer:

HCMed Innovations Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound management image-analysis software

Manufacturer:

KroniKare Pte. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection set, invasive

Manufacturer:

Kurin, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile extracorporeal gas exchange system catheter kit

Manufacturer:

MC3, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hygroscopic dental cement

Manufacturer:

NuSmile

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiotocography telemetric monitoring system transmitter

Manufacturer:

Nestmedic S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Obstetrical monitoring/analysis software

Manufacturer:

Nestmedic S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive lifting/tilting positioning system

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair glove

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair tyre

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

OK Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, enzyme spectrophotometry, rapid

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, point-of-care

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, kit, enzyme spectrophotometry

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw extractor, single-use

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, single-use

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical binoculars, reusable

Manufacturer:

ExamVision ApS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thyroid blocking immunoglobulin (TBI) IVD, kit, bioassay

Manufacturer:

Diagnostic Hybrids, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nasogastric tube holder, noninvasive

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-adhesive device retention bandage

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Postsurgical brassiere, non-antimicrobial

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube neck holder, reusable

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental wedge, single-use

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Composite dental impression material

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive air jet system

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band retainer

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band, single-use

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

DAS Medical International, SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

LED dental light, battery-powered

Manufacturer:

Den-Mat Holdings, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin detection IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assistive scooter, electric-motor-driven

Manufacturer:

Eurogreen International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

Everyway Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous incontinence-control electrical stimulator

Manufacturer:

Everyway Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Frame/rail/pole device holder

Manufacturer:

Fasciotens GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neonatal bed

Manufacturer:

Fasciotens GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope tissue removal cap, single-use

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible endoscopic biopsy handpiece/needle

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoperative ultrasound imaging transducer cover

Manufacturer:

Sheathing Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, laboratory

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, point-of-care

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketone (acetoacetate) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, kit, enzyme spectrophotometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine blood IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine creatinine IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine ketone IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine leukocyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine nitrite IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine nitrite IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine protein IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine specific gravity IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine specific gravity IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand/finger splint, reusable

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee immobilizer

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, professional

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient-worn bone growth electromagnetic stimulator

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy ultrasound system

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist orthosis

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece/electrode holder, reusable

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device adhesive remover

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitrectomy contact lens, reusable

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Mycone Dental Supply Co. Inc., t/a Keystone Industries

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hydraulic/pneumatic external knee prosthesis

Manufacturer:

NABTESCO CORPORATION ACCESSIBILITY INNOVATIONS COMPANY

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechatronic external knee prosthesis

Manufacturer:

NABTESCO CORPORATION ACCESSIBILITY INNOVATIONS COMPANY

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal hernia truss, reusable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand/finger splint, reusable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar cushion

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbosacral spine orthosis, flexible

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder immobilizer/orthosis, reusable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracolumbosacral spine orthosis, flexible

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Toe separator

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tubular support bandage, Hevea-latex

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand/finger stable-position orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone lever/elevator, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery dissector

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal guidewire

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal implant trial

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal rongeur

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant depth limiter

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Drilling power tool attachment, basic

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis alignment tool

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humeral body prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humeral head prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee femur prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medullary canal orthopaedic reamer, rigid

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw (non-sliding)

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic chisel

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Osteotomy guide, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reverse shoulder cup prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reverse shoulder head prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total reverse shoulder prosthesis

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total shoulder prosthesis

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biological stain control IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal parasite specimen concentration kit IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, fixative

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, no additive

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, transport buffer/medium

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Formalin substitute solution IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neutral buffered formalin IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum specimen liquefaction/decontamination kit IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leg procedure positioner

Manufacturer:

Quantum OPS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, reusable

Manufacturer:

RadScan Medical Equipment, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow-disarticulation prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external hip prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Composite dental impression material

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, laboratory

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental precision attachment simulator/analog, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ligation clip, metallic

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery ligation clip applier

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery ligation clip applier

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic tissue manipulation forceps, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic tissue manipulation forceps, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular scissors probe-tip, reusable

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical probe, reusable

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blanket/pad infant phototherapy unit

Manufacturer:

Lumitex Medical Devices, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External pledget

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External pledget

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Isolation gown, single-use

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze roll/sheet

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitric oxide delivery unit, system-based

Manufacturer:

Mallinckrodt Manufacturing LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitric oxide delivery unit, system-based

Manufacturer:

Mallinckrodt Manufacturing LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitric oxide delivery unit, system-based

Manufacturer:

Mallinckrodt Manufacturing LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone awl, reusable

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, external

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cone beam computed tomography system, head/neck

Manufacturer:

ALLIAGE S/A INDUSTRIAS MEDICO ODONTOLOGICA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metallic suture, multifilament

Manufacturer:

Aptos LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye wash cup

Manufacturer:

ArcScan, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear

Manufacturer:

AViTA Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tibial insert

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system application software

Manufacturer:

CorTechs Labs, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held-detector nuclear medicine system

Manufacturer:

Dilon Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gravity enema set

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality physical therapy system

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perineal orifice incontinence-control electrical stimulation system probe, reusable

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular intervention infusion catheter

Manufacturer:

Embolx, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bronchial balloon catheter

Manufacturer:

Pulmonx Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bronchoscopic catheter

Manufacturer:

Pulmonx Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Emphysematous lung sealant

Manufacturer:

Pulmonx Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endobronchial valve delivery catheter

Manufacturer:

Pulmonx Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemorrhoidal surgical stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery manual linear cutting stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, non-cutting

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray tube housing assembly, diagnostic

Manufacturer:

Chronos Imaging LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable public automated external defibrillator

Manufacturer:

CU Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cystic fibrosis IVD, control

Manufacturer:

Quantimetrix Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Full blood count IVD, control

Manufacturer:

Quantimetrix Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Quantimetrix Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species total antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Circulating immune complex (CIC) IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement component B IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement component C3a IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement component C5a IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C4/C4c IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Human herpesvirus nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, reagent

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid colorimetric, self-testing

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-hydroxybutyrate IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, electrometry

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin detection IVD, reagent

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, home-use

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, control

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

Sugarmate, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External pledget

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, non-antimicrobial, single-use

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vinyl examination/treatment glove, non-powdered

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Digit tourniquet, manual

Manufacturer:

Mar-Med Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-powered hand prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hydraulic/pneumatic external knee prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Passive wrist prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic tissue manipulation forceps, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic scissors, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic scissors, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, single-use

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, single-use

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic soft-tissue manipulation forceps, probe-like, reusable

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Young Microbrush LLC dba Microbrush International

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Saliva absorbent

Manufacturer:

Young Microbrush LLC dba Microbrush International

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, external

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical torque wrench, reusable

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Caplugs, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, single-use

Manufacturer:

Ondine Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Oon Corp Resources (M) Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality therapeutic radiation phantom, test object

Manufacturer:

Sun Nuclear Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Solid-state-semiconductor radiation measuring probe

Manufacturer:

Sun Nuclear Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

PathAI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Suture retention device

Manufacturer:

Fasciotens GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, monopolar, single-use

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrointestinal/airway foreign body retrieval basket, single-use

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, digital

Manufacturer:

Firefly Global

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

Firefly Global

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder glenoid fossa prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral medicine dropper

Manufacturer:

Comar, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, non-hermetic

Manufacturer:

Comar, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, single-use

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental coating, tooth-desensitizing, professional

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Matrix metalloproteinase-9 (MMP-9) IVD, kit, rapid ICT, clinical

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone alkaline phosphatase (BALP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement factor H IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type I C-terminal propeptide (PICP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Manufacturer:

Tempus AI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bench-top keratometer

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bench-top keratometer

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal topography system

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manually-adjusted lensmeter, line-powered

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic spectral-domain optical coherence tomography system

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system tube

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray digital imaging system workstation application software

Manufacturer:

iCAD, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Incipio Devices SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mandible-repositioning sleep-disordered breathing orthosis

Manufacturer:

ProSomnus Sleep Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Cellview Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

Click Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant nappy

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological laser beam guiding handpiece

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological laser beam guiding handpiece

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system cannula, reusable

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system generator

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

American Prosthetic Components, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/non-ISO80369-standardized linear connector

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/non-ISO80369-standardized small-bore multichannel connector

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral tube extension

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrostomy depth sizer

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrostomy tube

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General surgical procedure kit, non-medicated, single-use

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric tube holder, noninvasive

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Phoenix Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental acrylic resin

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

Sugarmate, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Accelerator system quality assurance device

Manufacturer:

Sun Nuclear Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation electrometer

Manufacturer:

Sun Nuclear Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Solid-state-semiconductor radiation measuring probe

Manufacturer:

Sun Nuclear Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical operating table base

Manufacturer:

Surgical Tables Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

Restorative Care of America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

Restorative Care of America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extracorporeal circuit waste bag

Manufacturer:

Advance Medical Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone awl, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone grafting cannula

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulator

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment impression cap

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental irrigation/aspiration syringe

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental rongeur

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula soft tip

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow immobilizer

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gauze packer

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General external orthopaedic fixation system implantation kit, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General surgical procedure kit, non-medicated, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive medium

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter/tubing connector securement clip

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/Luer linear connector

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral tube extension

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrojejunostomy tube

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrostomy button

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intestinal/urinary stoma button

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric feeding tube

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric feeding tube

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Incipio Devices SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/examination garment kit

Manufacturer:

Protect Gloves Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automated ophthalmic refractometer

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CAD/CAM software

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manually-adjusted lensmeter, line-powered

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic instrument table, line-powered

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, battery-operated

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Phoropter, electric

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Visual acuity projector

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Visual acuity projector

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system tube

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made lower-limb orthosis

Manufacturer:

Icarus Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Icarus Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Ideal Living LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, reusable

Manufacturer:

AdvancedCPR Solutions® LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal cavity stent, removable, prefabricated

Manufacturer:

Alaxo GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Creatinine IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, kit, enzyme spectrophotometry

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood cell lysis reagent IVD

Manufacturer:

STEMCELL Technologies Canada Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered isotonic saline reagent IVD

Manufacturer:

STEMCELL Technologies Canada Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnetic cell separation reagent IVD

Manufacturer:

STEMCELL Technologies Canada Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone-angle protractor

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental elevator, tooth/root

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental guided surgery registration/navigation fiducial marker

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template retention pin

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental precision attachment fitting/adjustment tool

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental root separator

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical probe, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical scissors

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extra-gynaecological surgical mesh, metal

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose bowl, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pressure infusor, manual, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual bone mill

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Maxillofacial bone wire/bar

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal chisel

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal probe, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal probe, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid arthroscope, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel blade remover

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interphalangeal joint arthrodesis implant

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Advance Medical Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin topical coupling gel

Manufacturer:

Advance Medical Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Specimen preparation enzyme reagent IVD

Manufacturer:

Bonraybio Co., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Spermatozoa chromatin dispersion (SCD) kit IVD

Manufacturer:

Bonraybio Co., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental material mixing nozzle

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental polishing cup, single-use

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gingival retraction cord, non-medicated

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polychloroprene examination/treatment glove, non-powdered

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyisoprene surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyisoprene surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Ovation Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Ovation Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand/finger stable-position orthosis

Manufacturer:

Ovation Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic polymer semi-permeable film dressing, adhesive

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver trial

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pacing/defibrillation lead suture sleeve

Manufacturer:

Oscor Inc.

Type:

Active Implantable Device

Registration Date:

Nov 26, 2024

Wrist orthosis

Manufacturer:

Ovation Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation shielding apron

Manufacturer:

Palmero Healthcare, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair brake handle grip

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle continuous passive motion exerciser

Manufacturer:

Ormed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder continuous passive motion exerciser

Manufacturer:

Ormed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

25-Hydroxy vitamin D3 IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anaemia-related analyte IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin analyser IVD, home-use

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin detection IVD, control

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood glucose/blood pressure monitoring system, home-use

Manufacturer:

Labstyle Innovations Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Zest Anchors, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

OK Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, kit, multiple technologies

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, kit, multiple technologies

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Air-filled chair cushion

Manufacturer:

Cascade Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest

Manufacturer:

Cascade Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Case Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive medium

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-body orifice lubricant

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin topical coupling gel

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin topical coupling gel

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, single-use

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw-extraction orthopaedic reamer, single-use

Manufacturer:

PB Swiss Tools AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular guide-catheter, single-use

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vein pick

Manufacturer:

Oscor Inc.

Type:

Active Implantable Device

Registration Date:

Nov 26, 2024

Multiple spinal region orthosis

Manufacturer:

Ovation Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic shoe, non-customized

Manufacturer:

Ovation Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation shielding apron

Manufacturer:

Palmero Healthcare, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

Quantimetrix Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care, battery-powered

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, control

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care, battery-powered

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus antigen IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen deoxypyridinoline IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen pyridium crosslink IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement complex SC5b-9 IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement component C1 inhibitor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C3/C3c IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Bordetella species nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human parainfluenza virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osteocalcin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trichomonas vaginalis nucleic acid IVD, control

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Automated ophthalmic refractometer

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CAD/CAM software

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multidisciplinary medical image management software

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic examination slit lamp

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, battery-operated

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Optical low coherence reflectometry (OLCR) biometer

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perimeter, automatic

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Visual acuity projector

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system tube

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system tube

Manufacturer:

I.C. Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray digital imaging system workstation application software

Manufacturer:

iCAD, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, kit, enzyme immunohistochemistry

Manufacturer:

KDx Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Abdominal binder, single-use

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, single-use

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode/transducer strap, single-use

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube holder

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary catheter holder

Manufacturer:

Dale Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system irrigation handpiece

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic reaming aid material

Manufacturer:

Danville Materials

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical binoculars, reusable

Manufacturer:

Den-Mat Holdings, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm immobilizer

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid localized thermal therapy system control unit

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid localized thermal therapy system pack, reusable

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot orthosis

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy ultrasound system applicator

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder immobilizer/orthosis, reusable

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Static/intermittent powered traction system, mobile

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization container mat

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cast shoe, reusable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal binder, reusable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clavicle orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mud-filled chair cushion

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Upper-limb mechanical weight exerciser, lever/pulley-cable

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/ENFit linear connector

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, single-use

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automated lensmeter

Manufacturer:

6over6 Vision Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmodiastimeter

Manufacturer:

6over6 Vision Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vision self-testing software

Manufacturer:

6over6 Vision Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Visual acuity projector

Manufacturer:

6over6 Vision Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone collection scraper

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental dressing forceps, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure aligner

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw analog, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Desk mount

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual dental burnisher, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic anchoring screw

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic pliers

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary panoramic dental x-ray system, analogue

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration cannula, illuminating, single-use

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tourniquet cuff, reusable

Manufacturer:

ACE Surgical Supply Company, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw (non-sliding)

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

ADSM a Tyber Medical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Upper-limb traction wrap/trap, single-use

Manufacturer:

Advance Medical Designs, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

Ahlstrom-Munksjö Specialties

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood lancet, single-use

Manufacturer:

Acon Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, kit, chromogenic

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care, line-powered

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin/hematocrit IVD, kit, electrometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketone (acetoacetate) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total haemoglobin (totHb) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine bilirubin IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine glucose IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine glucose IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine ketone IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine pH IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine urobilinogen IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine urobilinogen IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gingival retraction kit

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gingival retraction solution

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gingival retraction solution

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument rinsing agent

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Click Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic shoe, adapted

Manufacturer:

Click Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369-3-standardized oral syringe

Manufacturer:

Comar, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic suction collection container

Manufacturer:

Alleva Medical Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acid-alcohol solution IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biological stain control IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Decolourising solution IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, home-use

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide adhesion agent IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum liquefaction/decontamination reagent IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum specimen liquefaction/decontamination kit IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

Quantum OPS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical electrode lubricant

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray corner protector, reusable

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray liner

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization container filter, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument maintenance lubricant

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular lens-insertion cartridge

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual intraocular lens injector, reusable

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic examination slit lamp

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tinted non-prescription spectacle lens

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic shoe, non-customized

Manufacturer:

Schein Orthopädie Service KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table orthopaedic extension

Manufacturer:

Starr Frame LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment impression cap

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant analog

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant plug

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, non-portable

Manufacturer:

AViTA Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

AViTA Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, electric

Manufacturer:

AViTA Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system holder/tip, single-use

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, non-cutting

Manufacturer:

Reach Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality skin surface treatment system generator

Manufacturer:

Aerolase Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, paediatric, single-use

Manufacturer:

CU Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable public semi-automated external defibrillator

Manufacturer:

CU Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological solid-state laser system

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality skin surface treatment system generator

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray system generator, stationary

Manufacturer:

EMD Technologies Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid localized thermal/compression therapy system control unit

Manufacturer:

NICE Recovery Systems, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance electrode array, single-use

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stump sock

Manufacturer:

Trulife Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis finishing component, non-customized

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external ankle-foot prosthesis

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external knee prosthesis

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracolumbosacral spine orthosis, rigid

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal implant trial

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal implant trial

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal implant trial

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile medical equipment stand, non-powered

Manufacturer:

Verathon Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement extractor, manual

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periosteal elevator, reusable

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internally-anchored endoscopic retractor

Manufacturer:

Virtual Ports Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internally-anchored endoscopic retractor applier

Manufacturer:

Virtual Ports Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair bracket

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mammographic x-ray phantom, test object

Manufacturer:

Sun Nuclear Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot orthosis

Manufacturer:

Restorative Care of America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand orthosis

Manufacturer:

Restorative Care of America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Restorative Care of America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal breathing aid, internal, reusable

Manufacturer:

RhinoMed Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/emergency suction cannula, non-illuminating, reusable

Manufacturer:

Synaptive Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

Incipio Devices

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

Incipio Devices

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Mycone Dental Supply Co. Inc., t/a Keystone Industries

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cavity varnish

Manufacturer:

Mycone Dental Supply Co. Inc., t/a Keystone Industries

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

NABTESCO CORPORATION ACCESSIBILITY INNOVATIONS COMPANY

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resilient dental precision attachment

Manufacturer:

Servo-Dental GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Sheathing Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary drain

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary drain

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cast shoe, reusable

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromyography monitor

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose calliper, plastic

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Partial-rebreathing oxygen face mask

Manufacturer:

DJO, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, internal

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tamp, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humeral head prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humeral head spacer prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee tibia prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic broach

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic broach

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant calibration pin

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant calibration pin

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantation hammering attachment

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic instrument surgical connector

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic osteotome

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic reamer guide

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, internal

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pin-driving power tool attachment

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reverse shoulder head prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose warming cabinet, stationary

Manufacturer:

Enthermics Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Audiometric ear tip

Manufacturer:

Etymotic Research, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open surgical site internal light

Manufacturer:

Lumitex Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Phototherapy infant blanket

Manufacturer:

Lumitex Medical Devices, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

MaiMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clamp jaw cover, non-sterile

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning agent

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound irrigation cannula

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound irrigation cannula

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dry medical towel/wipe, single-use

Manufacturer:

Bonraybio Co., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Semen specimen collection container

Manufacturer:

Bonraybio Co., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sperm concentration indicator IVD, control

Manufacturer:

Bonraybio Co., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Spermatozoa/semen analyser IVD

Manufacturer:

Bonraybio Co., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Spermatozoa/semen analyser IVD, semi-automated

Manufacturer:

Bonraybio Co., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal cleaning solution

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

STEMCELL Technologies Canada Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Analytical non-scalp cutaneous lead

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical non-scalp cutaneous lead

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance electrode array, reusable

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance system, tomographic

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External breast prosthesis

Manufacturer:

Trulife Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external ankle-foot prosthesis

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw (non-sliding)

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw (non-sliding)

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantation sleeve, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar-management dressing, reusable

Manufacturer:

Biodermis LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Artificial airway stylet, reusable

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Artificial airway stylet, single-use

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Frame/rail/pole device holder

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid laryngopharyngoscope

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

VitalConnect, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antiseptic swab

Manufacturer:

Ondine Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, professional

Manufacturer:

Ondine Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Oon Corp Resources (M) Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Implantable pulse generator port plug

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pacing/defibrillation lead electrical adaptor

Manufacturer:

Oscor Inc.

Type:

Active Implantable Device

Registration Date:

Nov 26, 2024

Polyisoprene surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection set, invasive

Manufacturer:

Kurin, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extracorporeal membrane oxygenator

Manufacturer:

MC3, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Preformed dental crown, temporary

Manufacturer:

NuSmile

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac catheterization laboratory computer

Manufacturer:

Opsens, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac catheterization laboratory computer

Manufacturer:

Opsens, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Opsens, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Emergency airway clearance suction pump, electric

Manufacturer:

OSCAR BOSCAROL SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose donor-organ preservation/transport system

Manufacturer:

Paragonix Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, professional, multichannel

Manufacturer:

Personal MedSystems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioelectrical signal analysis software

Manufacturer:

Persyst Development Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioelectrical signal analysis software

Manufacturer:

Persyst Development Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological laser beam guiding handpiece

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive medium

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic body contouring system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Starr Frame LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CT phantom, test object

Manufacturer:

Sun Nuclear Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser patient positioning system

Manufacturer:

Sun Nuclear Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Accelerator system quality assurance device

Manufacturer:

Sun Nuclear Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

Restorative Care of America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

RhinoMed Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient health record information system application software

Manufacturer:

iMDsoft Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical cushion cover

Manufacturer:

Trulife Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table patient pressure distribution pad, reusable

Manufacturer:

Trulife Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair seat cushion

Manufacturer:

Trulife Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external knee prosthesis

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic spine orthosis

Manufacturer:

Trulife

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metal-polymer composite spinal interbody fusion cage

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin container

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clinical management support software

Manufacturer:

UpToDate, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic ultrasound phantom, test object

Manufacturer:

Verathon Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose ultrasound imaging system

Manufacturer:

Verathon Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose medical foam padding, reusable

Manufacturer:

Biodermis LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar-management dressing, single-use

Manufacturer:

Biodermis LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Artificial airway stylet, reusable

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope sheath, single-use

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image display unit, colour

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope blade

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope blade

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic broach

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic reamer guide

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Viscot Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiography telemetric monitoring system

Manufacturer:

VitalConnect, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, professional, single-channel

Manufacturer:

WR Medical Electronics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vibratory biothesiometer

Manufacturer:

WR Medical Electronics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye mask

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb tourniquet, manual, reusable

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suspension arm sling

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical microscope

Manufacturer:

Synaptive Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stereotactic surgery system probe, reusable

Manufacturer:

Synaptive Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryptococcus complex species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

IMMY, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical

Manufacturer:

IMMY, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum liquefaction/decontamination reagent IVD

Manufacturer:

IMMY, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nasal irrigation set, home-use

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Magnetic particle separation instrument IVD

Manufacturer:

Promega Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microsatellite instability IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Promega Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Optovue, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic spectral-domain optical coherence tomography system

Manufacturer:

Optovue, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive dynamic arm support system

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair legrest pad

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical bioimpedance system, tomographic

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance electrode array conductive skin adhesive tape

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance electrode array positioner

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance system, tomographic

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alternating electric field antimitotic cancer treatment system generator

Manufacturer:

Novocure GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Digital storage media

Manufacturer:

Novocure GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular modelling software

Manufacturer:

HeartFlow, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn lamp

Manufacturer:

ExamVision ApS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Footrest

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient transfer sliding board

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair headrest

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair seat cushion

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair steering/control unit

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, kit, rapid ICT, self-testing

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical

Manufacturer:

Biomerica, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid marker IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

Aalto Scientific, Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, control

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, reagent

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, control

Manufacturer:

Polymer Technology Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Case Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

CTK Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wheelchair bracket

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair brakes

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair handrim

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair head/trunk support, prefabricated

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Manufacturer:

Stealth Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, agglutination

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated albumin IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, reagent

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oesophageal varices haemostatic tube

Manufacturer:

Create Medic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urine-sampling urethral catheter

Manufacturer:

Create Medic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracolumbosacral spine orthosis, rigid

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertical non-powered traction system

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endaural surgical curette, single-use

Manufacturer:

EarWays Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

Everyway Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive skin pad, reusable

Manufacturer:

Everyway Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perineal orifice incontinence-control electrical stimulation system probe, reusable

Manufacturer:

Everyway Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Attendant-only-propelled wheelchair, non-bariatric

Manufacturer:

Leggero, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair, attendant/occupant-driven, front-wheels-operated, collapsible

Manufacturer:

Leggero, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Creatinine IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, spectrophotometry

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated albumin IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated albumin IVD, reagent

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, reagent

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, calibrator

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, reagent

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, control

Manufacturer:

Diazyme Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biological stain IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum liquefaction/decontamination reagent IVD

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical retraction system mounting frame, reusable

Manufacturer:

Quantum OPS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical cushion cover

Manufacturer:

RadScan Medical Equipment, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-wearable urine/faecal collection bag holder

Manufacturer:

RadScan Medical Equipment, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological general body-part positioner

Manufacturer:

RadScan Medical Equipment, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis finishing component, custom-made

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis finishing component, non-customized

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis finishing component, non-customized

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis socket liner

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external knee prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Passive shoulder prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bone matrix implant, metallic

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment trial

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure aligner

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template guide-sleeve

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ligation clip, metallic

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic scissors, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic scissors, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic tissue manipulation forceps, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular retractor, single-use

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical instrument handle, manual

Manufacturer:

MicroSurgical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material cartridge-plunging applicator, single-component

Manufacturer:

Premier Dental Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Emergency airway clearance suction plunger

Manufacturer:

Dechoker LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Den-Mat Holdings, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental diode laser system

Manufacturer:

Den-Mat Holdings, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Den-Mat Holdings, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Isothermal nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

Quantimetrix Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine sediment IVD, control

Manufacturer:

Quantimetrix Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, reagent

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Placental growth factor (PLGF) IVD, control

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Placental growth factor (PLGF) IVD, kit, fluorescent immunoassay

Manufacturer:

Quidel Cardiovascular Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, powdered

Manufacturer:

Hartalega Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

iSchemaView, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump software, data-display

Manufacturer:

Tandem Diabetes Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric spinal interbody fusion cage

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal/ENT/orthopaedic surgical probe, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthroscopic access cannula, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone file/rasp, manual, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone graft funnel

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic-access dilator, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metallic spinal interbody fusion cage

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantation hammering attachment

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic osteotome

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humeral head spacer prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Joint/spinal manipulator, mechanical

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee tibia prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medullary canal orthopaedic reamer, rigid

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation implant alignment tool

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patella prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reverse shoulder cup prosthesis trial, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder reverse/standard adaptor prosthesis trial

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total reverse shoulder prosthesis

Manufacturer:

Encore Medical L.P.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical non-scalp cutaneous electrode

Manufacturer:

Etymotic Research, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical non-scalp cutaneous lead

Manufacturer:

Etymotic Research, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hospital stretcher, powered

Manufacturer:

Eurogreen International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Everyway Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture retention device

Manufacturer:

Fasciotens GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose endoscopic needle, single-use

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope video camera

Manufacturer:

Firefly Global

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic light source unit, battery-powered

Manufacturer:

Firefly Global

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose digital medical camera lens, extraocular

Manufacturer:

Firefly Global

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-orifice ultrasound imaging transducer cover, basic

Manufacturer:

Sheathing Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

Manufacturer:

Sheathing Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Sheathing Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Topical coupling gel, sterile

Manufacturer:

Sheathing Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Airway device cleaning utensil, noninvasive, reusable

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant oral pacifier

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neonatal positioning/nesting device

Manufacturer:

Small Beginnings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological laser beam guiding handpiece

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system cannula, reusable

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality skin surface treatment system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-modality skin surface treatment system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking transfer paper

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system generator

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system generator

Manufacturer:

Solta Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fibreoptic light cable

Manufacturer:

Lumitex Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Barbed polyester suture, non-antimicrobial

Manufacturer:

Aptos LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system cannula, single-use

Manufacturer:

Aptos LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held deep-tissue electromagnetic stimulator

Manufacturer:

BioElectronics Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wireless patient monitor/sensor reporting software, layperson-use

Manufacturer:

Blue Spark Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wireless patient thermometer, single-use

Manufacturer:

Blue Spark Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uncoated knee tibia prosthesis, metallic

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, professional

Manufacturer:

DJO France SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system

Manufacturer:

Cutera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transgingival implant

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

IMMY, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

IMMY, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ear canal irrigation kit, single-use

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump reservoir

Manufacturer:

Tandem Diabetes Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump software, data-display

Manufacturer:

Tandem Diabetes Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

Tandem Diabetes Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm

Manufacturer:

Tandem Diabetes Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vision training software

Manufacturer:

Talshir Guy Medical Technologies Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

Temrex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band retainer

Manufacturer:

Temrex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental x-ray film holder, single-use

Manufacturer:

Temrex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

Thermoplastic Comfort Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Denture cleanser

Manufacturer:

Thermoplastic Comfort Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance electrode array conductive skin adhesive tape

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical impedance electrode array, reusable

Manufacturer:

Timpel S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, single-use

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal lubricant

Manufacturer:

Uberlube Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Artificial airway stylet, single-use

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video bronchoscope, single-use

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image display unit, colour

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile medical equipment stand, non-powered

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

MaRVis Interventional GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extracorporeal membrane oxygenator

Manufacturer:

MC3, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile extracorporeal gas exchange system catheter kit

Manufacturer:

MC3, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue saturation oximeter

Manufacturer:

Modulated Imaging, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared thermography interpretive software

Manufacturer:

Niramai Health Analytix Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter-tip transducer, pressure

Manufacturer:

Opsens, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Continuous passive motion joint exerciser

Manufacturer:

Ormed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin/creatinine ratio (ACR) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin/creatinine ratio (ACR) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, kit, chromogenic

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1C) analyser IVD

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin/hematocrit analyser IVD

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, reusable

Manufacturer:

Acon Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nephelometry/turbidimetry analyser IVD, automated/semi-automated

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, kit, enzyme spectrophotometry

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine albumin IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine bilirubin IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine blood IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine leukocyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine pH IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine protein IVD, kit, rapid colorimetric, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervicothoracic spine orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chest impact protector

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow joint orthosis component

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hallux valgus metatarsophalangeal orthosis

Manufacturer:

e-life International Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Isothermal nucleic acid amplification analyser IVD, point-of-care

Manufacturer:

ZIP Diagnostics Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Platelet aggregation analyser IVD

Manufacturer:

ZACROS Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Assay container IVD, single-use

Manufacturer:

ZACROS Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Platelet aggregation study IVD, reagent

Manufacturer:

ZACROS Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Evacuated blood collection tube IVD, anticoagulant

Manufacturer:

ZACROS Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Orthopaedic graft guide

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Cryobiological storage container

Manufacturer:

ThermoGenesis Corp.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Blood centrifugation system containment kit

Manufacturer:

ThermoGenesis Corp.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Arthroscopic obturator

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Promega Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Promega Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

Magnetic particle separation instrument IVD, semi-automated

Manufacturer:

Promega Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

Cardiac transseptal needle, single-use

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Haemostatic valve dilator

Manufacturer:

Oscor Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Intestinal/urinary stoma button

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Instrument tray, reusable

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Medical device adhesive remover

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Sterilization packaging, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument maintenance lubricant

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Bicompartmental knee prosthesis

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Uncoated unicondylar knee femur prosthesis

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Unicondylar knee prosthesis

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

ECA Medical Instruments

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Patient health record information system application software

Manufacturer:

iMDsoft Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Dental implant system

Manufacturer:

Implatek Saglik Ürünleri San. ve Tic. Ltd. Sti.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic surgical distractor, internal

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Manual intraocular lens injector, reusable

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Elbow-disarticulation prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

External limb prosthesis socket liner

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocautery system generator, line-powered

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocautery system handpiece

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocautery system handpiece

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Flexible endoscopic scissors, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Flexible endoscopic scissors, reusable

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Laparoscopic blunt dissector

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Open-surgery ligation clip applier

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical mallet

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Enteral tube extension, non-sterile

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Ear canal irrigation kit, single-use

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Artificial airway stylet, single-use

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Clamp jaw cover, non-sterile

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Instrument tray corner protector, reusable

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Sterilization container filter, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument guard, single-use, sterile

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Vascular booties

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Wound irrigation cannula

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Clamp jaw cover, non-sterile

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocautery system generator, line-powered

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Gastrostomy tube

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Clamp jaw cover

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Instrument tray liner

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Medical device cleaning agent

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Skin marking pen, single-use

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical vessel loop

Manufacturer:

Key Surgical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic surgical distractor, external

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical screwdriver, reusable

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Intraocular lens-insertion cartridge

Manufacturer:

RxSight, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

External limb prosthesis finishing component, custom-made

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Hydraulic/pneumatic external knee prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Mechanical-resistance external hip prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Mechanical-resistance external knee prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Passive wrist prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocautery system electrode

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocautery system generator, line-powered

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Laparoscopic blunt dissector

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic implantation hammering attachment

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Integrity Implants Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Joint prosthesis implantation kit, single-use

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic implant aiming/guiding block, single-use

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Uncoated unicondylar knee tibia prosthesis, metallic

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Antimicrobial wound irrigation solution, sterile

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Nasal aspirator, manual

Manufacturer:

NeilMed Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone wire

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Endoscope sheath, single-use

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Acetabular orthopaedic reamer

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Gauthier Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Ankle/foot orthosis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Body-powered hand prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

External limb prosthesis finishing component, non-customized

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Hip orthosis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Knee support orthosis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Passive shoulder prosthesis

Manufacturer:

Regal Prosthesis Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Foot-switch, electrical

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Ligation clip, metallic

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Open-surgery ligation clip applier

Manufacturer:

Microline Surgical, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Medicine cup, single-use

Manufacturer:

Comar, LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Enteral tube extension, non-sterile

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Glucose/ketone/lipid profile IVD, control

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Self-care monitoring/reporting software

Manufacturer:

Sugarmate, LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone wire

Manufacturer:

Tyber Medical LLC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Video intubation laryngoscope blade

Manufacturer:

Verathon Medical (Canada) ULC

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Ophthalmic spectral-domain optical coherence tomography system

Manufacturer:

Huvitz Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Glucose/ketone/lipid profile IVD, reagent

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid

Manufacturer:

General Life Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Knee femur prosthesis trial, reusable

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Knee tibia prosthesis trial, reusable

Manufacturer:

ConforMIS, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Vascular microcatheter

Manufacturer:

Creagh Medical Ltd.

Type:

General Medical Device

Registration Date:

Sep 15, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Aug 11, 2024

Surgical instrument torque limiter

Manufacturer:

Viant Medical, LLC

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Topical coupling gel, sterile

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Electrode conductive medium

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

General-body orifice lubricant, non-sterile

Manufacturer:

Parker Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Cardiac mapping system workstation

Manufacturer:

Stereotaxis, Inc

Type:

General Medical Device

Registration Date:

Jul 5, 2024

Cardiac mapping system

Manufacturer:

Stereotaxis, Inc

Type:

General Medical Device

Registration Date:

Jul 5, 2024

Medical image management system

Manufacturer:

Stereotaxis, Inc

Type:

General Medical Device

Registration Date:

Jul 5, 2024

Robotic surgical navigation system

Manufacturer:

Stereotaxis, Inc

Type:

General Medical Device

Registration Date:

Jul 5, 2024

Catheter-tip-to-tissue contact monitor

Manufacturer:

Stereotaxis, Inc

Type:

General Medical Device

Registration Date:

Jul 5, 2024

Robotic surgical navigation system application software

Manufacturer:

Stereotaxis, Inc

Type:

General Medical Device

Registration Date:

Jun 23, 2024

X-ray tube housing assembly, diagnostic

Manufacturer:

Chronos Imaging LLC

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Gastroschisis silo bag

Manufacturer:

Bentec Medical OpCo, LLC

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Intracavitary-circulation hyperthermia system

Manufacturer:

ThermaSolutions LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Thrombectomy rotational catheter

Manufacturer:

Vetex Medical Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Well-Life Healthcare Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

X-ray tube housing assembly, diagnostic

Manufacturer:

Chronos Imaging LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Atomizing surgical topical solution applicator

Manufacturer:

ThermaSolutions LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Diagnostic x-ray system generator, stationary

Manufacturer:

EMD Technologies Incorporated

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Diagnostic x-ray system generator, stationary

Manufacturer:

EMD Technologies Incorporated

Type:

General Medical Device

Registration Date:

Apr 11, 2024

ENFit/non-ISO80369-standardized linear connector

Manufacturer:

Applied Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental bone matrix implant, synthetic

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Cervicothoracic spine orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Intraperitoneal-circulation hypothermia system administration kit

Manufacturer:

ThermaSolutions LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Multidisciplinary medical image management software

Manufacturer:

Syntermed, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hip/knee orthosis

Manufacturer:

Ongoing Care Solutions Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental delivery system

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Wheelchair brake handle grip

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Jan 13, 2023

Wheelchair/chair occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Jan 13, 2023

Assistive dynamic arm support system

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Jan 13, 2023

Wheelchair/chair occupant restraint/support

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Jan 13, 2023

Ankle/foot orthosis

Manufacturer:

Bodypoint, Inc.

Type:

General Medical Device

Registration Date:

Jan 13, 2023

Hypodermic needle, single-use

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 29, 2022

Metered-delivery hypodermic syringe/needle

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 29, 2022

Blood collection set, invasive

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 29, 2022

Insulin syringe/needle, safety

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 29, 2022

General-purpose syringe, single-use

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 29, 2022

Peripheral intravenous cannula

Manufacturer:

Retractable Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 29, 2022

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Aug 11, 2022

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Aug 11, 2022

Electrosurgical handpiece, reusable

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Aug 11, 2022

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Manufacturer:

Dr. Frigz International (PVT) Ltd.

Type:

General Medical Device

Registration Date:

Aug 11, 2022

General specimen microscopy slide IVD, single-use

Manufacturer:

Alpha-Tec Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 8, 2022

Multiple form 25-hydroxy vitamin D IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

Quidel Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Feb 25, 2022

Dental appliance fabrication material, thermoplastic

Manufacturer:

Thermoplastic Comfort Systems, Inc.

Type:

General Medical Device

Registration Date:

Jan 24, 2022

Sleep-disordered breathing nasopharyngeal stent, reusable

Manufacturer:

Alaxo GmbH

Type:

General Medical Device

Registration Date:

Dec 31, 2021

Alternating electric field antimitotic cancer treatment system generator

Manufacturer:

Novocure GmbH

Type:

General Medical Device

Registration Date:

Oct 15, 2021

Alternating electric field antimitotic cancer treatment system transducer array

Manufacturer:

Novocure GmbH

Type:

General Medical Device

Registration Date:

Oct 15, 2021

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Oct 12, 2021

Nitrile examination/treatment glove, non-powdered, antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Oct 12, 2021

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Oct 12, 2021

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Hartalega NGC Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Oct 12, 2021

Screw endosteal dental implant, two-piece

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 20, 2021

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 20, 2021

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 20, 2021

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

MegaGen Implant Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 20, 2021

Endoscope tissue removal cap, single-use

Manufacturer:

Sumitomo Bakelite Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Sumitomo Bakelite Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Endoscopic overtube, single-use

Manufacturer:

Sumitomo Bakelite Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

DexCom, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Guangdong Transtek Medical Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 19, 2021

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Guangdong Transtek Medical Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 19, 2021

Flexible endoscopic biopsy forceps, single-use

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 18, 2021

Biliary/urinary stone retrieval basket, single-use

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 18, 2021

Stereotactic surgery system probe, reusable

Manufacturer:

Synaptive Medical Inc.

Type:

General Medical Device

Registration Date:

Aug 18, 2021

Gastrointestinal endoscopic clip, short-term

Manufacturer:

Finemedix Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 18, 2021

Rechargeable battery pack

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Epidural needle, non-threaded

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Surgical implant/trial-implant/sizer holder, single-use

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Surgical torque wrench, reusable

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Active implantable device control magnet

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Soft-tissue/mesh anchor, non-bioabsorbable

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Neurosurgical procedure kit, non-medicated, single-use

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Medical ruler, reusable

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Implantable pulse generator port plug

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Personal device holder, reusable

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Implantable spinal cord electrical stimulation system programmer

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Neural-tissue electrical stimulation lead adaptor

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Implant battery charger

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Electrosurgical cable adaptor

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Central nervous system electrical stimulation system lead stylet

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Vascular graft tunneller

Manufacturer:

Nevro Corporation

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jun 22, 2021

Ophthalmic spectral-domain optical coherence tomography system

Manufacturer:

Optovue, Inc.

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Intraocular lens-insertion cartridge

Manufacturer:

AST Products, Inc.

Type:

General Medical Device

Registration Date:

Apr 27, 2021

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

AST Products, Inc.

Type:

General Medical Device

Registration Date:

Apr 27, 2021

Manual intraocular lens injector, single-use

Manufacturer:

AST Products, Inc.

Type:

General Medical Device

Registration Date:

Apr 27, 2021

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Apr 19, 2021

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Apr 19, 2021

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Sri Trang Gloves (Thailand) Public Company Limited

Type:

General Medical Device

Registration Date:

Apr 19, 2021

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 31, 2021

Urine analyser IVD, laboratory, semi-automated

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 31, 2021

Glucose/ketone/lipid profile IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 31, 2021

Glucose/ketone/lipid profile IVD, control

Manufacturer:

Acon Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 31, 2021

Data sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

Last updated: December 2025