Medical Specialties
21 specialties • 7,018+ device types
BY SPECIALTY
Global Medical Device Directory
A unified global medical device database. Search and compare medical device registrations from multiple countries in one integrated system. Currently featuring USA and Brazil registration data, using the FDA device classification system as the universal standard.
Browse 7,000+ medical device types with real-world regulatory data, cross-border comparisons, and worldwide approval intelligence. Free unified directory powered by Pure Global AI.
🌍 Unified Global System • Multi-Country Data • One Search, Multiple Markets
Viewing: Unknown (0 device types)
Device Class:
Select a specialty to view device types
All Unknown device types (894)
- 3d Laser Scanning System
- 5-Fluorouracil Assay
- Ablation Catheter, Renal Denervation
- Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
- Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
- Absorbable Coronary Drug-Eluting Stent
- Absorbable Synthetic Wound Dressing
- Acid, Hyaluronic, Intraarticular
- Acute Coronary Syndrome Event Detector
- Adhesive, Tissue For Aneurysmorrhaphy
- Agent, Bulking, Injectable For Gastro-Urology Use
- Agent, Injectable, Embolic
- Agent, Occluding, Vascular, Permanent
- Aid, Visual, For Nausea
- Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
- Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
- Air Traffic Control
- Alfapump System
- Alignment Laser Product
- Analytical Measuring And Detection Laser Product
- Analyzer, Diagnostic, Fiber Optic (Colon)
- Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
- Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
- Anti-Stick Glass Syringe
- Anti-Theft Detector (Non-Eas)
- Antibody To Htlv-1, Elisa
- Antibody, Monoclonal Blocking, Hiv-1
- Antigen, Cancer 549
- Antigen(Complexed),Prostate Specific,(Cpsa)
- Aortic Heart Valve, More Than Minimally Manipulated Allograft
- Aortic Stent
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
- Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)
- Apparatus, Vestibular Analysis
- Applicator, Hyperthermia, Deep Heating, Ultrasound
- Applicator, Hyperthermia, Interstitial
- Applicator, Hyperthermia, Superficial, Rf/Microwave
- Artificial Chordae Tendinae Delivery System
- Artificial Heart
- Artificial Iris
- Aspiration Therapy System
- Aspirator, Ultrasonic
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Assay, Interleukin
- Assay, Oral Direct Thrombin Inhibitor
- Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
- Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
- Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
- Audio System/Radio
- Auto Focus Camera
- Automated Breast Ultrasound
- Automated Insulin Dosing Device System, Bihormonal Control
- Automated Insulin Dosing , Threshold Suspend
- Automated Insulin Dosing Device System, Single Hormonal Control
- Automotive Accessory, Automobile Or Transport Vehicle
- Automotive Radar
- Babesia Spp. Serological Reagents
- Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy
- Barrier, Absorbable, Adhesion
- Barrier, Adhesion, Cardiovascular
- Bartonella Spp. Serological Reagents
- Beta 2-Microglobulin Apheresis Column
- Betatron, Non-Medical
- Black Light
- Bladder System
- Bone Marrow Collection/Transfusion Kit
- Bone Marrow Processing Device For Clinical Use
- Bone Void Filler, Syringe
- Bottle Fill Checker
- Braf Mutation Kit
- Bronchial Thermoplasty System
- Burn Kit With Drug
- Button, Nasal Septal
- Cabinet X-Ray Explosive Detection Systems
- Cabinet X-Ray, Industrial
- Cabinet X-Ray, Security (Includes Baggage X-Ray)
- Cabinet X-Ray, Vehicle And Cargo
- Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
- Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma
- Cancer-Related Germline Gene Mutation Detection System
- Cap, Cervical, Contraceptive
- Cap, Cooling (Infants)
- Cardiac Ablation Percutaneous Catheter
- Cardiac Support Mesh Wrap
- Caries Detection Product With Drug Or Biologic
- Catheter Introducer
- Catheter, Balloon For Retinal Reattachment
- Catheter, Balloon, Transcervical
- Catheter, Balloon, Urethral, Drug-Coated
- Catheter, Coronary, Atherectomy
- Catheter, Nephrostomy
- Catheter, Percutaneous (Valvuloplasty)
- Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Catheter, Percutaneous, Long Term, Intraspinal
- Catheter, Sampling, Chorionic Villus
- Cathode Ray Tubes
- Cb Amateur Radio
- Cd-R, Cd-Rw Recorder
- Cd, Cd-Rom Player
- Cephalometric Devices
- Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses
- Chemiluminescent Immunoassay System
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Cleaner
- Cleanser, Root Canal
- Clothes Dryer
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Cold-Cathode Gas Discharge Tubes
- Collision-Avoidance Laser System
- Column, Adsorption, Low Density, Lipoprotein
- Columns, Immunoadsorption In Extracorporeal Systems
- Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
- Computer-Assisted Personalized Sedation System
- Container, Frozen Donor Tissue Storage
- Continuous Glucose Monitor, Implanted, Adjunctive Use
- Continuous Ventilator
- Continuous Ventilator, Minimal Ventilatory Support
- Contrast Media, Ultrasound
- Controller, Closed-Loop Blood Glucose
- Controller, Closed-Loop, Blood-Pressure
- Cooler, Esophageal And Gastric
- Cooler, Prostatic
- Cord, Retraction
- Coronary Covered Stent
- Coronary Drug-Eluting Stent
- Coronavirus Antigen Detection Test System.
- Coronavirus Marker Detection
- Cosmetology Uv Lamp
- Counterfeit Detection
- Countertop Sanitizer
- Covered Stent Vascular Connector, Hemodialysis Access Circuit
- Covid-19 Multi-Analyte Antigen Device
- Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
- Covid-19 Test Home Collection Kit Devices
- Critical Care Ventilator
- Cross-Sectional Mammographic Xray System
- Crown And Bridge Material, Resin Based
- Cultured Epithelial Autograft
- Cultured Human Cell Skin Dressing
- Cup, Eye
- Cushion, Hemorrhoid
- Cyclotron,Non-Medical
- D And C Tray
- Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
- Decontamination Systems For N95 Respirators
- Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Defibrillator, Implantable, Dual-Chamber
- Denture, Cosmetic Only
- Dentures, Full
- Dentures, Partial
- Device, Acupressure
- Device, Ahf, Automated Cryoprecipitation
- Device, Angioplasty, Laser, Coronary
- Device, Cystometric, Air
- Device, Dermal Replacement
- Device, Electrical Dental Anesthesia
- Device, Fertility Diagnostic, Proceptive
- Device, Hemostasis, Vascular
- Device, Inflation, Middle Ear
- Device, Peritoneal Access, Subcutaneous, Implanted
- Device, Removal, Pacemaker Electrode, Percutaneous
- Device, Sensing, Optical Contour
- Device, Testicular Hypothermia
- Device, Thermal Ablation, Endometrial
- Device, Thermal, Hemorrhoids
- Device, Ultrasonic, Thermal Ablation
- Device. Laser Peripheral Angioplasty
- Diagnostic Low Electric Field
- Diagnostic X-Ray Equipment (Noncertified)
- Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
- Dielectric Heaters, Induction Heaters, Rf Sealers
- Digital Breast Tomosynthesis
- Digital Display Monitor
- Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
- Dna-Probe, Human Chromosome
- Docetaxel / Paclitaxel Assay
- Dorsal Root Ganglion Stimulator For Pain Relief
- Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Dressing, Wound And Burn, Interactive
- Dressing, Wound And Burn, Occlusive
- Dressing, Wound, Drug
- Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- Drug-Coated Peripheral Transluminal Angioplasty Catheter
- Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Drug-Eluting Sinus Stent
- Dvd, Bluray, Or Hd Recorder
- Dvd, Dvd-Rom, Bluray, Hd Player
- Ecarin Clotting Time
- Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
- Electric Blanket
- Electrical Impedance Spectrometer
- Electrical Stimulation Bladder System
- Electrical Tumor Treatment Fields
- Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
- Electrode, Stabilized Epidural Spinal
- Electronic Article Surveillance (Eas)
- Electronic Media, Hyperacusis
- Electronic Media, Nausea
- Electrosurgical, Radio Frequency, Refractive Correction
- Embolization Agent, Vascular
- Emergency Resuscitator
- Emergency Ventilator
- Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
- Enzyme Immunoassay, Fetal Fibronectin
- Enzyme Immunoassay, Methotrexate
- Enzyme Immunoassay, Phencyclidine
- Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
- Eua Faceshields
- Excimer Laser System
- Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure
- Extracorporeal Shock Wave Treatment
- Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
- Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- Fastener, Fixation, Biodegradable, Hard Tissue
- Femtosecond Laser System For Refractive Correction
- Fiber Optic Communication And Data Transfer
- Fiber Optic Instrument For Testing Optical Fibers
- Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions
- Filler, Bone Void, Non-Osteoinduction
- Filler, Bone Void, Recombinant Platelet-Derived Growth Factor
- Filler, Bone Void, Synthetic Peptide
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion
- Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
- First Aid Kit With Drug
- Fluid, Cytological Collection
- Fluid, Hysteroscopy
- Fluorescence Imaging For Breast Cancer Detection
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
- Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement
- Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
- Fluorescent Lamp
- Food Processing
- For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
- For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
- Forensics
- Forensics Laser
- Gastric Emptying Breath Test
- Gastrointestinal Liner System
- Gauging
- Gauze/Sponge, Internal
- General Purpose Laser Products
- General Wellness Product
- Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
- Generator, Shock-Wave, For Pain Relief
- Glue, Surgical, Arteries
- Gowns And Other Apparel
- Graft, Bypass, Coronary Artery
- Graft, Sclera, Reinforcement
- Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
- Guide-Star Laser System
- Hair Dryer
- Hand Washing Sanitizer
- Headframe
- Hearing Aid, Tactile
- Heart Valve, More Than Minimally Manipulated Allograft
- Heart-Valve, Allograft
- Heart-Valve, Mechanical
- Heart-Valve, Non-Allograft Tissue
- Hemibridge System
- Hemodialyzer, High Cut-Off
- Hemostatic Wound Dressing With Thrombin Or Other Biologics
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Hepatitis Delta Serological Reagents
- Hepatitis Viral B Dna Detection
- High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
- High Intensity Lamp
- High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)
- High Voltage Tubes
- High Voltage Vacuum Switches
- High-Power Laser Light Show
- High-Power Laser Light Show Projector
- Hiv Self-Tests
- Hologram Displaying Or Creating Laser Product.
- Humidifier
- Hyaline Membrane Disease Assay
- Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
- Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy
- Idylla Cdx Msi Test
- Iliac Covered Stent, Arterial
- Illuminator System For Blood Products
- Image Digitizer
- Imager, Breast, Electrical Impedance
- Immunoadsorption Column For Emergency Use
- Immunoassay For Blood Tacrolimus
- Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
- Immunohistochemistry Assay, Antibody, Ki-67
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Implant, Anti-Gastroesophageal Reflux
- Implant, Auditory Brainstem
- Implant, Cartilage, For Articular Cartilage Repair
- Implant, Cochlear
- Implant, Collagen For Non-Aesthetic Use
- Implant, Corneal, Refractive
- Implant, Dermal, For Aesthetic Use
- Implant, Dermal, For Aesthetic Use In The Hands
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Implant, Intragastric For Morbid Obesity
- Implant, Resorbable, For Articular Osteochondral Repair
- Implantable Bladder-Evacuation Electrical Stimulation System
- Implantable Cardioverter Defibrillator (Non-Crt)
- Implantable Pulse Generator
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Implantable Pulse Generator, Programmer And Battery Charger
- Implanted Brain Stimulator For Epilepsy
- Implanted Fecal Incontinence Device
- Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
- Implanted Subcortical Electrical Stimulator (Motor Disorders)
- Industrial Accelerator
- Industrial X-Ray
- Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
- Inhibitor, Peridural Fibrosis (Adhesion Barrier)
- Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
- Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)
- Instrument, Glucose, Noninvasive Technology
- Instrument, Ultrasonic Surgical
- Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
- Interferometric Position Measuring Product
- Interleukin 6
- Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
- Intestinal Stimulator
- Intra-Abdominal Pressure Monitoring Device
- Intracranial Aneurysm Flow Diverter
- Intracranial Coil-Assist Stent
- Intracranial Neurovascular Stent
- Intraocular Pressure Lowering Implant
- Intrasaccular Flow Disruption Device
- Intravascular Radiation Delivery System
- Intrusion Alarm/Security
- Investigational Use Only - Clinical Chemistry
- Investigational Use Only - Clinical Toxicology
- Investigational Use Only - Hematology
- Investigational Use Only - Immunology
- Investigational Use Only - Microbiology
- Investigational Use Only - Pathology
- Ion Beam Implanter
- Ir Data Transmit/Control
- Ir Free-Space Data Transmit/Control Laser
- Ir Intrusion Detector
- Ir Laser Illuminator Only/Night Vision System
- Ir Laser Illuminator With Alignment Aid/Night Vision System
- Ir Laser Intrusion Detection/Security System
- Ir Remote Controller
- Ir Security
- Irradiation, Blood Indicators
- Irradiator, Blood To Prevent Graft Versus Host Disease
- Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
- Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
- Japanese Encephalitis Virus Immunological/Serology Test
- Jewelry Cleaner
- Kit, Cell Screening, Fetal
- Kit, Cord Blood Collection
- Kit, Dna Detection, Human Papillomavirus
- Kit, Rna Detection, Human Papillomavirus
- Kit, Sample Collection, Hiv
- Kit, Test (Donors), For Bloodborne Pathogen
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Kit, Test, In Vitro Periodontal
- Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
- Kit, Test, Quality Control For Endotoxin
- Kit, Test, Saliva, Hiv-1&2
- Kit, Western Blot, Hiv-1
- Laboratory Developed Test
- Lacrimal Stents And Intubation Sets
- Laser Advertising Display System
- Laser Aiming Product, Non-Visible
- Laser Aiming Product, Visible
- Laser Automotive Lighting & Signals
- Laser Children'S Toy/Novelty Product
- Laser Cutter
- Laser Distance, Detection, Ranging (Lidar)
- Laser Fax Machine
- Laser For Pain Therapy
- Laser For Wound Healing
- Laser Holographic System
- Laser Holographic System For Experiments, Research, Or Prototype Development
- Laser Ignition Tool
- Laser Illuminated Lighting Instrument
- Laser Illuminated Projector
- Laser Marker Or Engraver, Industrial Or Commercial
- Laser Marker, Cutter, Or Engraver, Tabletop, Consumer
- Laser Micrometer
- Laser Mouse, Trackball, Or Similar
- Laser Pointer
- Laser Printer
- Laser Products (Pre-Standard)
- Laser Rangefinders, Time-Of-Flight Speed Measurement Products
- Laser Science Education Products
- Laser Sensing System
- Laser Target Designator
- Laser Therapy Product
- Laser Traffic Signal
- Laser Video Projector
- Laser Vision
- Laser Visual Display - Display Retinal Image, Non-Medical
- Laser Weapon (Military Or Police)
- Laser Welder
- Laser-Based Material Positioning System
- Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- Laser, Neurosurgical
- Laser, Neurosurgical, Argon
- Ldt, Approved By Nys Clep
- Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
- Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
- Ldt, Unmet Need Within An Integrated Healthcare System
- Leadless Cardiac Resynchronization Therapy (Crt)
- Led Diodes Sold As Components To Be Installed In Finished Electronic Products
- Led For Signaling/Tracking/Triggering
- Led Lamps Emitting Visible Light Intended To Be Used For Illumination Purposes
- Led Toys And Entertainment Products
- Leeches, Medicinal
- Left Ventricular Ejection Fraction Screening Tool
- Lens, Contact (Polymethylmethacrylate)
- Lens, Intraocular, Phakic
- Leukemia Translocation Panel Multiplex Test
- Ligaments And Tendons, Synthetic
- Light Source System, Diagnostic Endoscopic
- Light, Spectrum, Broad (Non-Medical)
- Lipoprotein, Low Density, Removal
- Liquid Crystal Display (Lcd)
- Lithotripter, Shockwave (For Treating Gallbladder Stones)
- Locator, Root Apex
- Lockbox (Export Only)
- Low Emission Leds As Indicators Or Decorations
- Low-Power Laser Light Show Projector
- Lung Tissue Sealant For Lung Volume Reduction
- Lymph Node Location System During Sentinel Biopsy Procedure
- Maggots, Medical
- Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
- Mammary Sizer
- Manipulator, Plunger-Like Joint
- Mask, Surgical, Eua Authorized
- Massager
- Material, Dressing, Surgical, Polylactic Acid
- Material, Embolization, Neurovascular, Polymerizing Or Precipitating
- Material, Implantable For Controlled Release, Cder Or Cber Led
- Materials Processing
- Materials Processing, Laboratories
- Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
- Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator
- Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)
- Media, Corneal Storage
- Medical Computers And Software For Ophthalmic Use
- Medical Waste/Sterilizer
- Medium, Contrast, Radiologic
- Mercury Vapor Lamp
- Mercury Vapor Lamp, Not Self-Extinguishing, R-Type
- Metabolic Neuromodulation System
- Metal Deposition Laser Product
- Metal Halide Lamp
- Metal Halide Lamp, Other
- Microelectronic Mask Or Chip Processing, Checking, And/Or Repair
- Microscope (Electron Beam), Non-Medical
- Microscopy Laser Instrument Or Accessory Products
- Microspheres Radionuclide
- Microtron, Non-Medical
- Microwave Lan
- Microwave Oven, Commercial
- Microwave Oven, Consumer
- Minoxidil Sulfotransferase Or Isoenzymes Test System
- Mitral Valve Repair Devices
- Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule
- Molecular Erythrocyte Typing Test
- Monitor, Blood-Flow, Cerebral, Thermal Diffusion
- Monitor, Intracranial Pressure, Implanted
- Monitor, Penile Tumescence
- Monitor, Pressure, Intracompartmental
- Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
- Monitor, Spine Curvature
- Monitor,Test,Hiv-1
- Monoclonal, Hiv-1
- Motion Detector/Occupancy
- Motor
- Mouthguard, Migraine/Tension Headache
- Mouthguard, Over-The-Counter
- Mouthguard, Prescription
- Mr-Guided Focused Ultrasound System
- Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
- Multi-Patient Circuit Connector
- Multiple Osteoarticular Pathogen Antigen Kit
- Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
- Nasal Spray, Systemic Delivery, Cder Or Cber Led
- Neurological Stimulation For Emergency Use
- Neuromodulator For Obesity
- Neurosurgical Ultrasonic Instruments
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
- Night Vision Scope
- Nitric Oxide Generator And Delivery System
- Non-Continuous Ventilator For Emergency Use
- Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
- Nondestructive Tests
- Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
- Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
- Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
- Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
- Occluder, Balloon, Vena-Cava
- Occluder, Internal Vessel, Temporary
- Occluder, Patent Ductus, Arteriosus
- One-Way Air-Leak Valve
- Ophthalmic Sealant
- Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
- Optical Diagnostic Device For Melanoma Detection
- Optoacoustic Imaging System
- Oral Wound Dressing
- Oral Wound Dressing W/Drug And/Or Biologic
- Organ Care System (Ocs) Heart System
- Orientia Spp. (Scrub Typhus) Serological Reagents
- Oscilloscope (Exempted)
- Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
- Oximeter, Fetal Pulse
- P2psa
- Pacemaker/Icd/Crt Non-Implanted Components
- Pad, Alcohol, Device Disinfectant
- Paraquat Assay
- Particle-Size Measuring Instrument
- Paste, Injectable For Vocal Cord Augmentation
- Patient Monitor With Independent Remote Display And Operation
- Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Percutaneously Delivered Prostheses And Tricuspid Valves
- Peripheral Blood Processing Device For Clinical Use
- Peripheral Blood Processing Device For Osteoarthritis
- Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
- Permanent Defibrillator Electrodes
- Personnel Security Backscatter X-Ray System
- Personnel Security Transmission X-Ray System
- Pest Controller
- Pest Repeller
- Photochemical Curing And Adhesive
- Photochemical Curing And Adhesive Laser
- Placental Alpha Microglobulin-1 Immunoassay
- Placental Growth Factor Test
- Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein
- Plug, Punctum
- Police Radar
- Polymer, Natural-Absorbable Gelatin Material
- Polymeric Neurovascular Embolization
- Polymerizing, Neurovascular Embolization Material
- Posterior Ratcheting Rod System
- Powered Communication System For Emergency Use
- Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
- Print Industry Plate Maker
- Process Control
- Processor, Cervical Cytology Slide, Automated
- Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product
- Product Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control Product
- Progenitor Cell Enumeration
- Projector
- Prosthesis, Ankle, Uncemented, Non-Constrained
- Prosthesis, Arterial Graft, Bovine Carotid Artery
- Prosthesis, Finger, Semi-Constrained, Metal/Polymer
- Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Prosthesis, Intervertebral Disc
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer
- Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Prosthesis, Ligament
- Prosthesis, Ligament, Ptfe
- Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
- Prosthesis, Mitral Valve, Percutaneously Delivered
- Prosthesis, Nail
- Prosthesis, Orthodontic
- Prosthesis, Posterior Spinal Elements
- Prosthesis, Retinal
- Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
- Prosthesis, Spinous Process Spacer/Plate
- Prosthesis, Suture, Cerclage
- Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
- Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal
- Prosthesis, Total Talus Replacement, Metal
- Prosthesis, Urethral Sphincter
- Prosthesis, Vas Deferens
- Prosthetic Disc Nucleus Device
- Prostrate Cancer Genes Nucleic Acid Amplification Test System
- Protective Barrier Enclosure
- Protective Barrier Enclosure With Negative Pressure
- Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Protector, Hearing (Circumaural)
- Protector, Hearing (Insert)
- Pulmonary Stent
- Pulmonary Valve Prosthesis Percutaneously Delivered
- Pulmonic Valved Conduit
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Pulse Generator, Permanent, Implantable
- Pulse-Generator, Program Module
- Pulse-Generator, Single Chamber, Sensor Driven, Implantable
- Pulse-Generator, Single Chamber, Single
- Pump, Drug Administration, Closed Loop
- Pump, Infusion, Implanted, Programmable
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Radioimmunoassay, Phencyclidine
- Ranging
- Reader, Cervical Cytology Slide, Automated
- Reagent, Blood Bank, Quality Control
- Reagent, Coronavirus Serological
- Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube
- Reagents, 2019-Novel Coronavirus Nucleic Acid
- Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
- Reagents, Monkeypox Virus Nucleic Acid.
- Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
- Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
- Reagents, Zika Virus Nucleic Acid
- Recorder, Attention Task Performance
- Refractive Corneal Implant
- Reherniation Reduction Device
- Remote Controller
- Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
- Replacer, Ureteral
- Replacer, Urethral
- Reprographics
- Research Laser
- Research Use Only/Clinical Chemistry Devices
- Research Use Only/Clinical Toxicology
- Research Use Only/Hematology Devices
- Research Use Only/Immunology Devices
- Research Use Only/Microbiology
- Research Use Only/Pathology
- Respiratory Humidifier For Emergency Use
- Restoration, Base Metal
- Restoration, Noble Metal
- Restoration, Porcelain
- Restoration, Porcelain-Fused-To-Metal
- Restoration, Resin
- Restoration, Resin, Crown And Bridge
- Rf Identification
- Rf-Excited Lighting
- Rf/Microwave Hyperthermia System, Cancer Treatment
- Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
- Right Ventricular Bypass (Assist) Device
- Ring, Endocapsular
- Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
- Saliva, Artificial
- Salivary Estriol Test
- Scaffold, Dissection Repair
- Scaffold, Infrapopliteal, Absorbable
- Scientific Crystallography
- Scientific Optical Instrument, Noncoherent
- Scientific Use Ultrasound Products
- Sealant, Dural
- Sealant, Polymerizing
- Securement Wound Dressing For Reduction Of Infection
- Security Accelerator
- Security System
- Security X-Ray System, Open Beam, Small
- Semi-Constrained Metal/Polymer Finger Joint Prosthesis
- Sensor, Electro-Optical (For Cervical Cancer)
- Sensor, Glucose, Implanted, Non-Adjunctive Use
- Sensor, Glucose, Invasive
- Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
- Sensor, Glucose, Invasive, Non-Adjunctive
- Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Separator, Semi-Automated, Blood Component
- Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
- Sewing Machine
- Shavers
- Shockwave Intravascular Lithotripsy System
- Shunt, Portosystemic, Endoprosthesis
- Silicone, Liquid, Injectable
- Single-Use Reprocessed Ultrasonic Surgical Instruments
- Skin Microneedling Manual/Automated Device (Export Only)
- Smart Meter
- Sodium Vapor Lamp
- Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
- Software, Blood Virus Applications
- Software, Management, Microplate Assay
- Solution, Cleaning / Lubricating, Artificial Eye
- Solution, Removal, Carries
- Solution, Sodium Hyaluronate
- Somatic Gene Mutation Detection System
- Sound Amplification Product
- Spectroscopy Instrument
- Spectroscopy, Ultraviolet Fluorescence
- Spermatocele, Alloplastic
- Spinal Fixation System
- Spinal Pedicle Screw, Fixation, Appliance System
- Static Electricity-Emitting Device, Cosmetic Use
- Stent Delivery System
- Stent Graft, Bypass, Superficial Femoral Artery
- Stent Graft, Infrapopliteal, Venous Arterialization
- Stent, Bladder, Fetal
- Stent, Carotid
- Stent, Central Venous
- Stent, Coronary
- Stent, Iliac
- Stent, Iliac Vein
- Stent, Renal
- Stent, Superficial Femoral Artery
- Stent, Superficial Femoral Artery, Drug-Eluting
- Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
- Stent, Urethral, External Sphincter, Permanent
- Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
- Stent, Urethral, Prostatic, Semi-Permanent
- Sterilizers, Non-Medical
- Stimulator, Autonomic Nerve, Implanted (Depression)
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
- Stimulator, Bladder
- Stimulator, Bone Growth, Non-Invasive
- Stimulator, Brain, Implanted, For Behavior Modification
- Stimulator, Electrical For Sperm Collection
- Stimulator, Electrical, Implanted, For Essential Tremor
- Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
- Stimulator, Electro-Acupuncture
- Stimulator, Fetal, Acoustic
- Stimulator, Functional Neuromuscular, Scoliosis
- Stimulator, Functional Walking Neuromuscular, Non-Invasive
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Stimulator, Invasive Bone Growth
- Stimulator, Low Electric Field, Tumor Treatment
- Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb
- Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
- Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
- Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
- Stimulator, Subcortical, Implanted For Epilepsy
- Stimulator, Thalamic, Epilepsy, Implanted
- Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
- Stimulator, Transdermal
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
- Stimulator, Vestibular Acceleration, Therapeutic
- Strip, Test Isoniazid
- Stun Gun
- Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
- Surgical Kit
- Surveying Laser Product
- Suture, Absorbable, Ophthalmic
- Suture, Cardiovascular
- Suture, Dental
- Suture, Nonabsorable, Ophthalmic
- Synchrotron, Non-Medical
- Synthetic Next-Generation Sequencing Quality Control And Filler Material
- System, Appendage Closure, Left Atrial
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
- System, Endovascular Graft, Aortic Aneurysm Treatment
- System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
- System, Esophageal Pacing
- System, Facet Screw Spinal Device
- System, Hemodynamic, Implantable
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- System, Identification, Contact Lens
- System, Identification, Hepatitis B Antigen
- System, Imaging, Fluorescence
- System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led
- System, Laser, Fiber Optic, Photodynamic Therapy
- System, Laser, Photodynamic Therapy
- System, Laser, Transmyocardial Revascularization
- System, Non-Coherent Light, Photodynamic Therapy
- System, Oxygen, Aqueous
- System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
- System, Photopheresis, Extracorporeal
- System, Rf/Microwave Hyperthermia, Cancer Treatment
- System, Separation, Hematopoietic Stem Cell
- System, Test, Alpha-Fetoprotein, Ria
- System, Test, Her-2/Neu, Ihc
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- System, Test, Home, Hiv-1
- System, Test, Total Antioxidant Status
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- System, Transdermal Delivery, Cder Or Cber Led
- Telephone Ringer
- Telescope, Implantable, Miniature
- Television Or Monitor, Non-Crt, Non-Medical, Video Display
- Television Receiver, General Purpose, Color
- Television Receiver, General Purpose, Monochrome
- Television Receiver, Medical Imaging, Color
- Television Receiver, Medical Imaging, Monochrome
- Television, Less Than 25kv And Less Than 0.1 Mr/Hr
- Temporary Non-Roller Type Left Heart Support Blood Pump
- Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
- Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device
- Test For Periprosthetic Joint Infection
- Test System, For Drugs Of Abuse
- Test, Anti-Tumor Cell Susceptibility
- Test, Breath Analysis, Volatile Organic Compounds
- Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
- Test, Donor, Cmv
- Test, Ecarin Clotting Time (Ect)
- Test, Equipment, Automated Bloodborne Pathogen
- Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
- Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Test, Nr2 Antibody
- Test, Phencyclidine (Pcp), Over The Counter
- Test, Platelet Antibody
- Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
- Test, Qualitative, For Hla, Non-Diagnostic
- Test, Quantitative, For Hla, Non-Diagnostic
- Test, Syphilis, Treponemal
- Test, Volatile Organic Compounds Breath Analysis
- Tester, Acoustic, Bone Quality
- Tissue Adhesive For Ophthalmic Use
- Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- Tissue Adhesive, Aortic Aneurysmorrhaphy
- Tissue Expander And Accessories
- Tissue Graft Of 6mm And Greater
- Tissue Graft Of Less Than 6mm
- Tissue Processing Kit
- Toilet Seat Sanitizer
- Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- Towel Cleaner
- Tracheostomy And Nasal Suctioning Kit
- Transcatheter Septal Occluder
- Transcatheter Septal Occluder (Atrial)
- Transcatheter Septal Occluder (Ventricular)
- Transdermal Test For Assessment Of Glomerular Filtration Rate
- Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
- Transvenous Temporary Phrenic Nerve Stimulator
- Tray, Leukocyte Typing
- Tricuspid Valve Repair Device, Percutaneously Delivered
- Tumor Gene Profiling Test
- Tungsten Halogen Lamp
- Tunnel/Conveyor
- Tv View Finder (Exempted)
- Tympanostomy Tube Delivery Product With Drug
- Ultrasonic Cutter
- Ultrasound, Hyperthermia, Cancer Treatment
- Upc Scanner Reader (Bar Code Reader)
- Uv Curing
- Uv Lamp For Home Or Business Uses
- Uv Lamp, Germicidal
- Uv/Ir Research
- Vagus Nerve Stimulator For Rheumatoid Arthritis
- Valve, Pulmonary
- Valve, Ureterovesicle
- Vapocoolant Device
- Vaporizer, Cder Or Cber Led
- Vehicle And Cargo X-Ray System, Mobile
- Vehicle And Cargo X-Ray System, Stationary
- Vending Machine
- Ventilator Tubing And Accessories
- Ventilator, High Frequency
- Ventilatory Assistance Helmet
- Ventricular (Assist) Bypass
- Vertebral Body Tethering System
- Veterinary Diagnostic Ultrasonic Products
- Veterinary Diagnostic X-Ray System
- Veterinary Laser
- Veterinary Optical Product
- Veterinary Therapy Ultrasonic Products
- Veterinary X-Ray Therapy System
- Veterinary, Microwave Medical Products
- Vials, Challenge, Endotoxin
- Video Monitor, General Purpose, Color
- Video Monitor, General Purpose, Monochrome
- Video Monitor, Medical Imaging, Color
- Video Monitor, Medical Imaging, Monochrome
- Visible Laser Illuminator
- Walkie-Talkie
- Water Immersion Labor Pool
- Water Purifier
- Wax, Bone
- Wearable Automated External Defibrillator
- Weather Doppler
- Welder
- Whole Blood Pre-Treatment T-Cell Enrichment Reagent
- Wireless (Cordless) Telephone
- Wound Covering (Composite Cultured Skin)
- Wound Dressing With Animal-Derived Material(S)
- Wound Dressings Containing Topical Analgesics
- Wound Dressings With Hydrocortisone
- X-Ray Controls - Fluoroscopic
- X-Ray Controls - Radiographic
- X-Ray Controls ? Combination
- X-Ray Diffraction
- X-Ray Field Indicator Light Field (Non-Laser)
- X-Ray Fluorescence
- X-Ray Image Receptor
- X-Ray Spectroscopy
- X-Ray Thickness Gauge
- Yersinia Spp. Reagents
- Zika Virus Serological Reagents (Emergency Use)