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PT. TAWADA HEALTHCARE

Authorized Representative in Indonesia

Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5
589 Products Represented
181 Manufacturers
Total Products
589
Manufacturers
181
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
206 products
35.0%
Kelas Resiko : B
152 products
25.8%
Kelas Resiko : C
177 products
30.1%
Kelas Resiko : D
54 products
9.2%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (589)
Complete portfolio registered with BPOM

QUANTUM 2 (RF 12000)

Manufacturer:

SMITH & NEPHEW INC, ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

QUARTET™ Left Heart Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

TWINFIX Ti Suture Anchors

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2025

SMITH & NEPHEW Fast Fix Instruments

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2025

QUICKFLEX™ µ Left Heart Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

ISOFLEX Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

HAETMED Small Steam Sterilizer

Manufacturer:

HAETMED (WUXI) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

SMITH & NEPHEW Genesis II Instrument

Manufacturer:

STRAITS ORTHOPAEDICS (MFG) SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 3, 2025

HAETMED Small Steam Sterilizer

Manufacturer:

HAETMED (WUXI) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

HAETMED Small Steam Sterilizer

Manufacturer:

HAETMED (WUXI) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

SMITH & NEPHEW Q-FIX Ancillary Surgical Instrument

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 3, 2025

SMITH & NEPHEW Genesis II Instrument

Manufacturer:

SMITH & NEPHEW., INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 30, 2025

ULTRA FAST-FIX Meniscal Repair System

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

FAST-FIX 360 Meniscal Repair System

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

MENISCAL STITCHER Instruments

Manufacturer:

SMITH & NEPHEW INC. ENDOSCOPY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 30, 2025

TWINFIX Ti Suture Anchors

Manufacturer:

SMITH & NEPHEW INC. ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

HEALICOIL PK Suture Anchor

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

HEALICOIL PK Suture Anchors

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2025

SMITH & NEPHEW Fast Fix Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 22, 2025

FANTA AF Files

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2025

V-TAPER Gold

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2025

V-TAPER Hand Files

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2025

FLUORODOSE Varnish Bubble Gum Flavor

Manufacturer:

CENTRIX, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

Q-FIX All-Suture Anchor

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 13, 2025

FANTA Stainless Steel Files

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 12, 2025

REDAPT Revision Femoral System

Manufacturer:

SMITH & NEPHEW INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 9, 2025

TWINFIX Ultra HA Suture Anchor

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 9, 2025

ENTRANT™ DR Implantable Cardioverter Defibrillators (ICDs)

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN BHD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 8, 2025

LEGION XLPE Inserts

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 6, 2025

FANTA Surgical Mircoscope

Manufacturer:

SUZHOU SEMORR MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 4, 2025

JOURNEY II UK Instrument

Manufacturer:

SMITH & NEPHEW INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 4, 2025

CORI Instrument

Manufacturer:

STRAITS ORTHOPAEDICS (MFG) SDN BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 4, 2025

OPTISURE Defibrillation Lead

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2025

GALLANT ™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN BHD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2025

ENTRANT™ VR Implantable Cardioverter Defibrillators (ICD)

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN BHD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2025

Optivantage Dual-Head CT Contrast Delivery System

Manufacturer:

LIEBEL-FLARSHEIM COMPANY LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2025

FANTA MC File

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 3, 2025

REAL INTELLIGENCE CORI Surgical System

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2025

JOURNEY II UK Instrument

Manufacturer:

SMITH & NEPHEW INC. ENDOSCOPY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 2, 2025

FANTA Gutta Percha

Manufacturer:

SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 30, 2024

FANTA Paper Point

Manufacturer:

SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 30, 2024

FLUORODOSE Varnish

Manufacturer:

CENTRIX, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2024

MEDSYNAPSE RIS-PACS

Manufacturer:

MEDSYNAPTIC PVT. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

MINITAPE Suture

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION (MANSFIELD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2024

OPTISURE™ Defibrillation Lead

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 23, 2024

DETES Integral Dental Unit

Manufacturer:

DETES (GD) MEDICAL SUPPLIES CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2024

REDAPT Instrument

Manufacturer:

STRAITS ORTHOPAEDICS (MFG) SDN BHD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2024

VINCISMILE Enamel Coating Resin

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

SIGTUPLE AI100 with Shrava – Urine Analyzer

Manufacturer:

SIGTUPLE TECHNOLOGIES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

FAST FIX Meniscal Repair Systems

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

ULTRABRAID

Manufacturer:

TELEFLEX MEDICAL DE MEXICO, S. DE R.L. . FROM CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2024

ACUFEX Pro Handheld Instruments

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

SMITH & NEPHEW Dyonics Blades and Burrs

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

R3 Instruments

Manufacturer:

MPS MICRO PRECISION SYSTEMS AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 12, 2024

FAST FIX FLEX Meniscal Repair System

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2024

ULTRA FAST-FIX Meniscal Repair System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

ANTHEM Total Knee System

Manufacturer:

SMITH & NEPHEW OPERATIONS SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2024

DURATA ™ Defibrillation Lead

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 5, 2024

SMITH & NEPHEW ANTHEM Total Knee System Instruments

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 28, 2024

SMITH & NEPHEW HIP Arthroscopy Instrument Set

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 28, 2024

OSTEORAPTOR Suture Anchor

Manufacturer:

SMITH & NEPHEW INC. ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

CLEANEST Disposable Electronically Pulsed Lavage System

Manufacturer:

GUANGZHOU CLEAN MEDICAL PRODUCTS MANUFACTURING CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2024

VINCISMILE Enamel Coating Resin

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2024

SMITH & NEPHEW 560 Camera System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2024

HUGE Denture Base Polymers

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2024

ENDOBUTTON Instruments

Manufacturer:

TELEFLEX MEDICAL DE MEXICO, S. DE R.L. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 20, 2024

SMITH & NEPHEW Xenon Light Source

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

INTELLIO 4K Surgical Imaging System

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

DURATA™ Defibrillator Lead

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 20, 2024

DURATA Defibrillation Lead

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 20, 2024

SMITH & NEPHEW Guidewire

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

HUGE A-Silicone for Bite Registration

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2024

JOURNEY II UK Knee System

Manufacturer:

SMITH & NEPHEW INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2024

BIOSURE HA Interference Screw

Manufacturer:

SMITH & NEPHEW INC. ENDOSCOPY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

POLARSTEM Instruments

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS AG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2024

ELLIPSE™ DR Implantable Cardioverter Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

TENDRIL STS Pacing Leads

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

BUCK Cement Restrictors

Manufacturer:

STRAITS ORTHOPAEDIC (MFG) SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2024

ELLIPSE™ VR Implantable Cardioverter Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

REAL INTELLIGENCE CORI Instrument

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2024

HUGE Light Curing Tray

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2024

SMITH & NEPHEW TRUEPASS Disposable Needle

Manufacturer:

ARTHROCARE CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2024

SMITH & NEPHEW Easy Tray Lid Plastic

Manufacturer:

SYMMETRY MEDICAL MANUFACTURING INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2024

SMITH & NEPHEW 3.8 mm Tapered Awl, Disposable

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2024

ELLIPSE VR Implantable Cardioverter Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

GENESIS II Knee System

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

GENESIS II Knee System

Manufacturer:

SMITH & NEPHEW., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

UNIFY Assura ™ Cardiac Resynchronization Therapy Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

ELLIPSE DR ™ Implantable Cardioverter Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

SMITH & NEPHEW ANTHEM Total Knee System Instruments

Manufacturer:

SUZHOU AHNO MEDICAL DEVICES CO, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2024

SMITH & NEPHEW Genesis II Instrument

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 4, 2024

ISOFLEX™ Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 3, 2024

QUADRA ASSURA MP Cardiac Resynchronization Therapy Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 1, 2024

UNIFY ASSURA Cardiac Resynchronization Therapy Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 1, 2024

QUADRA ASSURA Cardiac Resynchronization Therapy Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 1, 2024

GENESIS II Knee System

Manufacturer:

SMITH AND NEPHEW OPERATIONS SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

REFLECTION Acetabular System

Manufacturer:

STRAITS ORTHOPAEDICS (MFG) SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

SMITH & NEPHEW Universal Acetabular Cancellous Screw

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

LEICA M525 F20 Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 30, 2024

CORI Instrument

Manufacturer:

SMITH & NEPHEW INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2024

SYNERGY Instruments

Manufacturer:

STRAITS ORTHOPAEDICS (MFG), SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2024

SMITH & NEPHEW Image Management System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

VINCISMILE Resin Modified Glass Ionomer Cement

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

VINCISMILE Light Cure Dental Adhesive

Manufacturer:

RIZHAO HUGE BIOMATERIALS COMPANY, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

REFLECTION XLPE Liners

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

SMITH & NEPHEW Tray to case POLARSTEM 21000675

Manufacturer:

SYMMETRY MEDICAL MALAYSIA SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 23, 2024

GENESIS II Implants Articular Insert

Manufacturer:

SMITH&NEPHEW ORTHOPAEDICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

WEREWOLF Wand

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2024

ACCU-PASS Suture Shuttle

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 21, 2024

SPIDER 2 Limb Positioner

Manufacturer:

MICROTEK DOMINICANA, SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 21, 2024

SMITH & NEPHEW Tandem Instruments

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 18, 2024

LEGION Knee System Implants (1)

Manufacturer:

SMITH & NEPHEW., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

LEGION Knee System Implants (2)

Manufacturer:

SMITH & NEPHEW., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

POLYDENTIA Sectional Matrix Systems

Manufacturer:

POLYDENTIA SA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2024

SMITH & NEPHEW Accu-Pass Disposable Suture Shuttle

Manufacturer:

ARTHROCARE CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2024

SMITH & NEPHEW Hip Positioning System

Manufacturer:

MING FAI INDUSTRIAL (SHENZEN) CO. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2024

SMITH & NEPHEW Lens 4K Scopes

Manufacturer:

HENKE-SASS WOLF, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2024

FORTIFY ASSURA VR Implantable Cardioverter Defibrillator

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 17, 2024

ENDURITY Pulse Generator

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

ASSURITY MRI Pulse Generator

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

ENDURITY Core

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

QUADRA Allure MP™

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

ASSURITY MRI Pulse Generator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

ELLIPSE DR

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

ASSURITY MRI Pulse Generator

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

LEGION Total Knee System

Manufacturer:

SMITH & NEPHEW OPERATIONS SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2024

TANDEM Bipolar Hip System

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2024

GENESIS II Implants Constrained Articular Insert

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2024

R3 Acetabular System

Manufacturer:

SMITH AND NEPHEW OPERATIONS SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2024

ENDURITY Core Pulse Generator

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 14, 2024

ENDURITY™ Pulse Generator

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 14, 2024

R3 Acetabular System

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2024

REFLECTION Acetabular System

Manufacturer:

SMITH & NEPHEW INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2024

ENDURITY Core Pulse Generator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 14, 2024

GENESIS II Long Stem

Manufacturer:

STRAITS ORTHOPAEDIC (MFG) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2024

ENDURITY Core

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 10, 2024

GENESIS II Knee System

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2024

ELLIPSE VR Implantable Cardioverter Defibrillator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 10, 2024

ELLITE PASS Premium

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

ACUFEX Extremety Instrument

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

SYNERGY Instruments

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS, GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 9, 2024

SMITH & NEPHEW R3 Instruments

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 9, 2024

SMITH & NEPHEW Endobutton Instruments

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

OSTEORAPTOR Suture Anchors

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

BIOSURE HA Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2024

ALLURE RF Cardiac Resynchronization Therapy Device Pulse Generator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

ENDURITY Pulse Generator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

SMITH & NEPHEW Versitip Adaptors

Manufacturer:

PT. TEAM-METAL INDONESIA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

QUADRA ALLURE MP Cardiac Resynchronization Therapy Device, Pulse Generator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 1, 2024

TWINFIX Ultra HA

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

TRUEPASS Suture Pass

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

TWINFIX Ti Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

FANTA Irrigation Needle

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

SPIDER 2 Limb Positioner

Manufacturer:

MOUNTAIN INTEGRATED MEDICAL DEVICES INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

SPIDER 2™Limb Positioner

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

TWINFIX Ti Instruments

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

SYNERGY Hip System

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

TANDEM Bipolar Hip System

Manufacturer:

SMITH & NEPHEW INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

SYNERGY Hip System

Manufacturer:

SMITH AND NEPHEW OPERATIONS, SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

ECTRA II Instrument

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION (MANSFIELD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

LEICA Proveo 8 Ophthalmic Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2024

SMITH & NEPHEW ANTHEM Total Knee System Instruments

Manufacturer:

CANWELL MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2024

ENDOBUTTON Fixation System

Manufacturer:

SMITH & NEPHEW INC.. ENDOSCOPY DIVISIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2024

ORIENTER Group A Rotavirus Antigen Test Kit (Colloidal Gold)

Manufacturer:

SICHUAN ORIENT BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

SMITH & NEPHEW Endobutton Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2024

SYNERGY Hip System

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

ENDOBUTTON Fixation Device

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

ULTRATAPE Suture

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION (MANSFIELD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

SYNERGY Instruments

Manufacturer:

OSARTIS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 20, 2024

ULTRABRAID Suture

Manufacturer:

SMITH & NEPHEW.INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

ASSURITY MRI Pulse Generator

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 20, 2024

WEREWOLF + Power Cord/Manual

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

ULTRABRAID Suture

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

OPTIS ™ Integrated Next Imaging System

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2024

ORIENTER Fully Automatic Digital Feces Analyzer

Manufacturer:

SICHUAN ORIENT BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

ORIENTER Fecal Morphology Quality Control

Manufacturer:

SICHUAN ORIENT BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

OPTIS™ Mobile Next Imaging System

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2024

MPM Italia Firenze Motorized

Manufacturer:

L.M. MEDICAL DIVISION S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 9, 2024

SMITH & NEPHEW Hip Positioning System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2024

CLEAR-TRAC Complete Disposable Cannula System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2024

SMITH & NEPHEW Dyonics 25 Fluid Management System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2024

MYQUICKMAT Classico Starter kit

Manufacturer:

POLYDENTIA SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 4, 2024

SYNERGY Instruments

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 3, 2024

SMITH & NEPHEW HIP Arthroscopy Instrument Set

Manufacturer:

SMC MEDICAL MANUFACTURING PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

Lens 4K System

Manufacturer:

SMITH & NEPHEW, INC. ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

MyVeo

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2024

ULTIPACE Pacing Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 29, 2024

ULTIPACE Pacing Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2024

SMITH & NEPHEW T-Max

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MYQUICKMAT All-round introkit

Manufacturer:

POLYDENTIA SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2024

SMITH & NEPHEW Lens Camera

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MYQUICKMAT Forte Starter Kit

Manufacturer:

POLYDENTIA SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2024

SYNERGY Instruments

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2024

REFLECTION Instruments

Manufacturer:

STRAITS ORTHOPAEDICS (MFG) SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2024

SMITH & NEPHEW Disposable Knives

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2024

SMITH & NEPHEW Clear-Trac Complete Disposable Cannula System

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MYCLIP 2.0 Sectional Matrix Systems

Manufacturer:

POLYDENTIA SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2024

BICEPTOR Tenodesis System (Instrument)

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

Q-FIX All-Suture Anchor System

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

CONTOUR Acetabular Rings

Manufacturer:

SMITH & NEPHEW INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

TWINFIX ULTRA HA Instrument

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

SMITH & NEPHEW Osteoraptor Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

CROSSTRAC Hip Guide System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

REFLECTION Instruments

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

SMITH & NEPHEW Reamer Dome

Manufacturer:

GREATBATCH MEDICAL S. DE R.L. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

SMITH & NEPHEW Graftmaster III

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

SMITH & NEPHEW HEALICOIL PK Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

Surgical Instrument Steel

Manufacturer:

ADITYA DISPOMED PRODUCTS PVT. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

ACUFEX ACL/PCL System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

FIRSTPASS MINI Suture Pass

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

DYONICS Power II Control System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

MULTIFIX S Ultra Knotless Suture Anchor

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

ANTHEM Total Knee System

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

ULTRABUTTON Adjustable Fixation Device

Manufacturer:

ARTHROCARE CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

LEGION XLPE Inserts

Manufacturer:

SMITH & NEPHEW, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

OPTISTAR Elite MR Contrast Delivery System

Manufacturer:

LIEBEL-FLARSHEIM COMPANY LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

ILLUMENA NEO Contrast Delivery System

Manufacturer:

LIEBEL- FLARSHEIM COMPANY LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2024

FANTA DENTAL MATERIALS iRoot Pro

Manufacturer:

CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

MI Trial Femoral Head

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ORIENTER Concentrated Cleaning Fluid

Manufacturer:

SICHUAN ORIENT BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

MI Trial Femoral Head

Manufacturer:

SMITH & NEPHEW. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ORIENTER Sample Diluent

Manufacturer:

SICHUAN ORIENT BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2024

SMITH & NEPHEW Arthroscopy Cart

Manufacturer:

ITD GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2024

MICRO VECTOR Instrument

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2024

POLARSTEM Detachable rasp

Manufacturer:

OHST MEDIZINTECHNIK AG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

ARTHROWAND Surgical Devices RF 12000

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

OPTIVANTAGE Dual Head Contras Delivery System In Computed Tomography

Manufacturer:

LIEBEL - FLARSHEIM COMPANY LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

ORIENTER Sample Collection Tube

Manufacturer:

SICHUAN ORIENT BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 31, 2024

OptiStar Elite MR Contrast Delivery System

Manufacturer:

LIEBEL-FLARSHEIM COMPANY LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

OPTIONE Single-Head CT Contrast Delivery System

Manufacturer:

LIEBEL-FLARSHEIM COMPANY LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

FIRSTPASS ST Suture Pass

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2024

Prismatherm II Blood Warmer

Manufacturer:

STIHLER ELECTRONIC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

VINCISMILE Invisible Orthodontic Appliance

Manufacturer:

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2024

WEREWOLF Foot Pedal

Manufacturer:

LINEMASTER SWITCH CORP

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2024

OptiOne Single-Head CT Contrast Delivery System

Manufacturer:

LIEBEL-FLARSHEIM COMPANY LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2024

Q-FIX Disposable Surgical Instrument

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2024

POLARSTEM

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2024

FANTA eFiller Endodontic Obturation Devices

Manufacturer:

CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2024

PRISMAFLEX Oxiris Set

Manufacturer:

GAMBRO INDUSTRIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

ULTRAFILTER U 9000

Manufacturer:

GAMBRO DIALYSATOREN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

POLYFLUX H

Manufacturer:

GAMBRO DIALYZER GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

REVACLEAR Capillary Dialyzer

Manufacturer:

GAMBRO RENAL PRODUCTS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

BAXTER AV Fistula Needles

Manufacturer:

NIPRO (THAILAND) CORPORATION LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

PRISMAFLEX M Set

Manufacturer:

GAMBRO INDUSTRIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

PRISMAFLEX HF Set

Manufacturer:

GAMBRO INDUSTRIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

PRISMASOL WILL

Manufacturer:

BIEFFE MEDITAL S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

PRISMAFLEX HF20 Set

Manufacturer:

GAMBRO INDUSTRIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

PRISMAFLEX

Manufacturer:

GAMBRO INDUSTRIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

PRISMAFLEX TPE Set

Manufacturer:

GAMBRO INDUSTRIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

POLYFLUX 6H Capillary Dialyzer

Manufacturer:

GAMBRO DIALYSATOREN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

NOVALINE Tubing Sets For Hemodialysis

Manufacturer:

VITAL HEALTHCARE SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

NOVAPLUME Disposable AV Fistula Needle Sets

Manufacturer:

BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

SOFTPAC C-Polyolefin Container

Manufacturer:

BIEFFE MEDITAL S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

REVACLEAR Capillary Dialyzer

Manufacturer:

GAMBRO DIALYZER GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

Wispex

Manufacturer:

CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

POLYFLUX 2H Capillary Dialyzer

Manufacturer:

GAMBRO DIALYSATOREN GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2024

CARESTREAM DENTAL CS 2100

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2024

THERANOVA

Manufacturer:

GAMBRO DIALYZER GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2024

U9000 Plus Ultrafilter

Manufacturer:

GAMBRO DIALYZER GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

POLYFLUX Capillary Dialyzer

Manufacturer:

GAMBRO DIALYZER GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

BICART Cartridge

Manufacturer:

GAMBRO DASCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

PRISMAX Software Version 3

Manufacturer:

GAMBRO DASCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

THERMAX Blood Warmer Unit

Manufacturer:

GAMBRO DASCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

FANTA Actor I Pro

Manufacturer:

CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

FANTA eHeater

Manufacturer:

CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

CC MEDICAL Arterial-Venous Fistula Set

Manufacturer:

HOSPITECH MANUFACTURING SERVICES SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2024

ORTHODRIVE LITE - MBQ - 708 Orthodrive Lite Modular Handpiece - Twin Trigger

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2024

CARESTREAM Dental Extraoral X-Ray System CS 8100

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM DENTAL CS 9600

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM Extra Oral Imaging System CS 8100 SC

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM Digital Imaging Sensor RVG 5200

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM Intraoral Source X-Ray System RVG 6200

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM CS 8100SC 3D

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM CS 8200 3D

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM Intraoral X-Ray System CS 2200

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM Intraoral Imaging Plate System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

CARESTREAM Intraoral Imaging Plate System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2024

ORTHODRIVE LITE Modular Handpiece-Single Trigger

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

ORTHODRIVE - MBQ-701 Two Speed Rotary Handpiece (BL) - Twin Trigger

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

ECO PULSE Pulse Lavage System

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

TRAUMADRIVE - DBN-470 Sagittal Saw Handpiece

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

GOFLO Pump

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

TRAUMADRIVE - MBU - 470 Handpiece - Twin Trigger

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

DAKO PD-L1 IHC 22C3 pharmDx

Manufacturer:

AGILENT TECHNOLOGIES, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 8, 2024

OSTEODRIVE MCI - 270 Handpiece - Straight Case (35k)

Manufacturer:

DE SOUTTER MEDICAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MIZUHO OSI Ultra Shoulder Positioner

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC, UNITED STATES

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 6, 2024

MIZUHO TRIOS Surgical Table System

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 6, 2024

ALLEGRO Mobile Imaging Table

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2024

DRX-Compass X-ray System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

DRX-Compass X-ray System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

UNINTECH Camera Light Source

Manufacturer:

UNINTECH GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

UNINTECH Camera Controller

Manufacturer:

UNINTECH GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

UNINTECH Reusable Surgical Intruments

Manufacturer:

UNINTECH GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

maXium smart Vac Smoke Evacuator

Manufacturer:

KLS MARTIN SE & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

UNINTECH Rigid Endoscopes

Manufacturer:

UNINTECH GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

INSITE Surgery Table

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC, UNITED STATES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

DRX-Compass X-ray System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 22, 2024

CARESTREAM Vita Flex CR System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

CARESTREAM DRYVIEW 6950 Laser Imaging System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

MIZUHO Hana Orthopedic Surgery Table

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 16, 2024

MIZUHO Modular Table System Advanced Control Base

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 14, 2024

MIZUHO ProAxis® Spinal Surgery Table

Manufacturer:

MIZUHO ORTHOPEDIC SYSTEMS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 14, 2024

DRX Plus Detector

Manufacturer:

CARESTREAM HEALTH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 6, 2024

CARESTREAM DRX-Evolution

Manufacturer:

CARESTREAM HEALTH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 6, 2024

MIZUHO Operating Table VS600Dj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

CARESTREAM Direct View Classic CR System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

CARESTREAM DRYVIEW 5950 Laser Imager

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

MIZUHO Operating Table MOT-VS700UKIj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

MOTION Mobile X-Ray System

Manufacturer:

BMI BIOMEDICAL INTERNATIONAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2024

DRX Plus 2530C Detector

Manufacturer:

CARESTREAM HEALTH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2024

DRX-Revolution Mobile X-Ray System

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2024

CARESTREAM Laser Imager

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2024

VEPRO EMR Manager PACS

Manufacturer:

VEPRO AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 4, 2024

CARESTREAM Dryview DVE Laser Imaging Film

Manufacturer:

RAYCO (XIAMEN) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 4, 2024

FOCUS 43C Detector

Manufacturer:

IRAY TECHNOLOGY TAICANG LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 1, 2024

DRX Revolution Mobile X-Ray System

Manufacturer:

CARESTREAM HEALTH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 1, 2024

FOCUS 35C Detector

Manufacturer:

IRAY TECHNOLOGY TAICANG LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 1, 2024

CARESTREAM Lux 35 Detector

Manufacturer:

CARESTREAM HEALTH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

CARESTREAM DRX-1 System

Manufacturer:

CARESTREAM HEALTH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

marVac Smoke Evacuator

Manufacturer:

KLS MARTIN SE & CO KG. (Freiburg)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

SMITH & NEPHEW Footprint PK Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 22, 2024

CARESTREAM DRX Transportable System

Manufacturer:

CARESTREAM HEALTH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2024

CARESTREAM Dryview DVE Laser Imaging Film

Manufacturer:

CARESTREAM HEALTH, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 22, 2024

LEICA Proveo 8 Ophthalmic Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 21, 2024

STERICUT 2

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

LEICA Proveo 8 Ophthalmic Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

LEICA ARveo 8 Stand System

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2024

LEICA ARveo 8 Microscope for Neurosurgery

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2024

LEICA PROVIDO Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2024

LEICA M822 Ophtalmic Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2024

LEICA M822 Ophtalmic Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2024

LEICA M530 OHX Surgical Microscope for Cranial & Spine Surgery

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2024

OSTEODRIVE MCI - 270 Handpiece - Straight Case (35k)

Manufacturer:

DE SOUTTER MEDICAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

ECO PULSE™ Pulse Lavage System

Manufacturer:

DE SOUTTER MEDICAL, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

ARTHRODRIVE DCA Shaver System

Manufacturer:

DE SOUTTER MEDICAL, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

STERICUT 6

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2024

STERICUT 4

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2024

CLEANCAST CC8 System Less Extraction

Manufacturer:

DE SOUTTER MEDICAL, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2024

STERICUT 1

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2024

CLEANCAST CC7 System with Extraction

Manufacturer:

DE SOUTTER MEDICAL, LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 2, 2024

PRISMAFLEX

Manufacturer:

GAMBRO DASCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2024

TENDRIL STS Pacing Lead

Manufacturer:

ABBOTT MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 20, 2024

TENDRIL STS Pacing Lead

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 20, 2024

FANTA Plugs

Manufacturer:

UNITED DENTAL CHANGZHOU

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 17, 2024

AK 98 Dialysis Machine

Manufacturer:

GAMBRO DASCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 10, 2024

CPS Locator 3D Catheters

Manufacturer:

CENTERPOINT SYSTEMS LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

ENVISION FLEX Wash Buffer ( 20x )

Manufacturer:

AGILENT TECHNOLOGIES DENMARK APS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2023

CIGARS Dermis Allograft

Manufacturer:

RTI SURGICAL, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2023

DAKO PD-L1 IHC 22C3 pharmDx

Manufacturer:

AGILENT TECHNOLOGIES, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2023

DAKO Monoclonal Mouse Anti-Human PD-L1 Clone 22C3

Manufacturer:

AGILENT TECHNOLOGIES, Inc. (CARPINTERIA)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2023

CC MEDICAL Hemodialysis Blood Tubing Set

Manufacturer:

HOSPITECH MANUFACTURING SERVICES SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2023

ENDURITY PM1162

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 15, 2023

ULTIRI Measurement System

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

MERLIN™ 2 Patient Care System Programmer

Manufacturer:

BENCHMARK ELECTRONICS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 19, 2023

FOCUS HD 35 Detector

Manufacturer:

IRAY TECHNOLOGY TAICANG LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2023

FOCUS HD 43 Detector

Manufacturer:

IRAY TECHNOLOGY TAICANG LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2023

GUERBET Sterile High-Pressure Angiographic Syringes for Single-Use

Manufacturer:

SHENZHEN BOON MEDICAL SUPPLY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2023

ORTHODRIVE Reciprocating Saw Handpiece (BL) - Two Speed

Manufacturer:

DE SOUTTER MEDICAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2023

ORTHODRIVE - DBC-700 Reciprocating Saw Handpiece (BL) - Single Speed

Manufacturer:

DE SOUTTER MEDICAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2023

OSTEODRIVE MCU – 470 Handpiece

Manufacturer:

DE SOUTTER MEDICAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

ORTHODRIVE - Sagittal Saw Handpiece

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2023

SIGTUPLE AI100 with Shonit – Blood Cell Count Analyzer

Manufacturer:

SIGTUPLE TECHNOLOGIES PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2023

STERICUT 3

Manufacturer:

DE SOUTTER MEDICAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2023

MIZUHO Operating Table VS600DHKj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2023

SMARTONE Vac

Manufacturer:

ZHEJIANG MEDSTAR TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2023

SMARTONE Handles

Manufacturer:

ZHEJIANG MEDSTAR TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2023

ORTHODRIVE - MBQ-700 Two Speed Rotary Handpiece (BL) - Single Trigger

Manufacturer:

DE SOUTTER MEDICAL, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2023

MIZUHO Operating Table 5602BW

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2023

MIZUHO Operating Table MOT-VS500SKj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2023

FORTIFY ASSURA ™ DR

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

QUADRA Assura

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

QUADRA Assura MP

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

FORTIFY Assura DR

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

FORTIFY Assura VR

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 22, 2023

SMARTONE Electrodes

Manufacturer:

KLS MARTIN GMBH + CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 20, 2023

MIZUHO Operating Table VS500DKj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

MIZUHO Operating Table VS600DHj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

MIZUHO Operating Table

Manufacturer:

MIZUHO CORPORATION, CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

MIZUHO Mobile Microsurgery Operating Table

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

MIZUHO Mobile Microsurgery Operating Table

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

MIZUHO Universal Operating Table

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 6, 2023

MIZUHO Operating Table VS600DKj

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

MIZUHO Hybrid Imaging Table for Intervention

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2022

KLS MARTIN HF Surgery ME MB 3, 'm" version

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 11 )

Manufacturer:

GEBRÜDER MARTIN GMBH., & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 15, 2022

ORODEKA Dental Root Canal Instruments

Manufacturer:

JINING ORODEKA MEDICAL EQUIPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 7, 2022

MAXIUM Smart C

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 23 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 19 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

KLS MARTIN Surgical Instrument Stainless Steel - Silicone

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

KLS MARTIN Retractor Kidney Tranplatation System

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2022

KLS MARTIN Surgical Instrument Stainless Steel-Brass

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 18, 2022

KLS MARTIN Surgical Instrument Titanium + Nickel-titanium alloy

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2022

KLS MARTIN Surgical Instrument Stainless Steel - Plastic

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2022

KLS MARTIN Surgical Instrument Silicone

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

KLS MARTIN Minor Basic Set II, General Surgery

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

KLS MARTIN Major Vaginal Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

KLS MARTIN Vasectomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2022

KLS MARTIN Surgical Instrument Plastic

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

KLS MARTIN Thoracotomy (Lung)

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

KLS MARTIN Tracheotomy Instrument Set

Manufacturer:

GEBRÜDER MARTIN GMBH., & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

KLS MARTIN Stichcing Set

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

KLS MARTIN Supplement Set, Thoracotomy

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

MARTIN Surgical Instrument Stainless Steel, Teflon and Plastic

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

KLS MARTIN Surgical Instrument Stainless Steel-Aluminium

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

KLS MARTIN marTract Retractor System

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 11, 2022

KLS MARTIN Tubectomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 10, 2022

KLS MARTIN Hernia and Appendix Set II

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 9, 2022

RAPID Rhino

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2022

KLS MARTIN Mini Laparatomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2022

KLS MARTIN Pap Smear Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2022

ACCU-PASS Suture Shuttle

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISON

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2022

KLS MARTIN Sinus Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 7, 2022

KLS MARTIN Minor Set I

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 12 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

KLS MARTIN Surgical Instrument Stainless Steel and Tungsten carbide

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

KLS MARTIN Thoracotomy (Lung) Children and Baby

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

KLS MARTIN Vaginal Speculum Set

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 2, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 18 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 2, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 10 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 2, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 21 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 1, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 17 )

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Stainless Steel (8)

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Liver Transplatation Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 13 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 14 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 22 )

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 16 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Titanium

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 7 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2022

KLS MARTIN Mastectomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 26, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 9 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 26, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 6 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2022

KLS MARTIN Major Surgery Set II

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2022

KLS MARTIN Vena Sectio Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2022

KLS MARTIN Hernia And Appendix For Children Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2022

KLS MARTIN Major Set I

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2022

KLS MARTIN Minor Vaginal Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2022

KLS MARTIN Hernia and Appendix Set I

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2022

KLS MARTIN Laminectomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2022

KLS MARTIN Basic Orthopedic Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 20, 2022

SMITH & NEPHEW Dyonics Power II Consumable

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

KLS MARTIN Kidney Transplatation Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 4 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2022

KLS MARTIN Craniotomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2022

KLS MARTIN Gynaecology Set

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2022

KLS MARTIN Laparatomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 15 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 3 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 5 )

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

KLS MARTIN Surgical Instrument Stainless Steel ( 2 )

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

KLS MARTIN Surgical Instrument Stainless Steel (1)

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

KLS MARTIN Tracheostomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2022

KLS MARTIN Mastoidectomy Set

Manufacturer:

GEBRÜDER MARTIN GMBH., & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2022

KLS MARTIN Basic Set, Vascular

Manufacturer:

GEBRÜDER MARTIN GMBH. & CO., KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 7, 2022

MICROSTOP Sterilization Container Systems

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

Dexis IS 3800W

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

MARSAFE Miniset Container

Manufacturer:

GEBRÜDER MARTIN GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2022

Dexis IS 3600

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2022

MAXIUM i-Version HF Electrosurgery Unit

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2022

Dexis IS 3700

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2022

KLS MARTIN ME MB 3 "i" version Electrosurgery Unit

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2022

HF MAXIUM M Version Electrosurgery Unit

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2022

KLS MARTIN HF Surgical Unit Minicutter

Manufacturer:

GEBRÜDER MARTIN GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2022

CLEANCART C

Manufacturer:

GAMBRO DASCO S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2022

CLEANCART A

Manufacturer:

GAMBRO DASCO S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

DAKO PD-L1 IHC 22C3 pharmDx

Manufacturer:

AGILENT TECHNOLOGIES, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 31, 2022

OPTIS Mobile System (C408661)

Manufacturer:

ABBOTT MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

OPTIS Integrated System (C408652)

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2022

DRAGONFLY OPTIS Imaging Catheter

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2022

LEICA M320 Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 21, 2022

SMITH & NEPHEW MULTIFIX S Ultra Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 17, 2022

BIORAPTOR PK 2.3 Suture Anchor

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2022

BIORAPTOR PK 2.3 Suture Anchor

Manufacturer:

SMITH & NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2022

ANTHEM Total Knee System

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2022

AMPLATZER Vascular Plug 4

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2022

AMPLATZER Vascular Plug II

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2022

AMPLATZER Vascular Plug

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2022

LEICA M844 Ophtalmic Surgical Microscope

Manufacturer:

LEICA INSTRUMENTS (SINGAPORE) PTE., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 31, 2022

DRAGONFLY OPSTAR™ Imaging Catheter

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 9, 2022

CONFIRM RX Insertable Cardiac Monitor Model DM3500

Manufacturer:

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2022

SMITH & NEPHEW Arthroscope HD

Manufacturer:

HENKE-SASS WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2022

SMITH & NEPHEW Reflection Reamer Domes

Manufacturer:

MPS PRECIMED SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 23, 2022

ACUFEX Handheld Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2022

SMITH & NEPHEW Genesis II Instrument

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 22, 2022

SMITH & NEPHEW R3 Acetabular System

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2022

CARESTREAM Medical X-ray Green / MXG Film

Manufacturer:

RAYCO (XIAMEN) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 10, 2022

COBLATOR II Controller System

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 9, 2022

REFLECTION Reamer Handle

Manufacturer:

GREATBATCH MEDICAL, S. DE R.L. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2022

SMITH & NEPHEW Image Management System 660HD-E

Manufacturer:

SMITH & NEPHEW., INC., ENDOSCOPY DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2022

SMITH & NEPHEW ANTHEM Total Knee System (Instruments)

Manufacturer:

STRAITS ORTHOPAEDICS (MFG) SDN., BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 2, 2022

SMITH & NEPHEW ANTHEM Total Knee System Instruments

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2022

SMITH & NEPHEW Wire Instruments Set

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 24, 2022

R3 Acetabular System

Manufacturer:

SMITH&NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 23, 2022

REFLECTION Instruments

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 22, 2022

VEPRO EMR Manager PACS

Manufacturer:

VEPRO AG

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2022

SMITH & NEPHEW Removal Tool Handle

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS, GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2022

R3 Acetabular System

Manufacturer:

SMITH&NEPHEW ORTHOPAEDICS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 21, 2022

BIORAPTOR Knotless Suture Anchor

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2022

BIOSURE HA Instruments

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2022

BIORAPTOR Instruments

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION, MANSFIELD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 9, 2022

SMITH & NEPHEW Passing Pin

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2022

BIORAPTOR Knotless Suture Anchor

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2022

EVAC 70 Xtra with Integrated Cable

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 3, 2022

REFLEX ULTRA 45 with Integrated Cable

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2022

SMITH & NEPHEW Universal Cancellous Screws

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 29, 2022

SMITH & NEPHEW Irrigation Pump

Manufacturer:

ARTHROCARE CORPORATION S.R.L, COYOL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 26, 2022

PROCISE LW Wand with Integrated Cable

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2022

FOOTPRINT PK Suture Anchor

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2022

TURBINATOR™ Wall

Manufacturer:

ARTHROCARE CORPORATION S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 21, 2022

COBLATOR II (8000E) System 240 V

Manufacturer:

ARTHROCARE CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 21, 2022

DAKO FLEX Monoclonal Mouse Anti-Human p63 Protein Clone DAK-p63 Ready to Use (Link)

Manufacturer:

AGILENT TECHNOLOGIES DENMARK APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2022

SMITH & NEPHEW Dyonics 25 Tube Set

Manufacturer:

SMITH & NEPHEW INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2022

REFLECTION Implants

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2022

REFLECTION implants

Manufacturer:

SMITH & NEPHEW ORTHOPAEDICS, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2022

OSTEORAPTOR W 1UB II BLUE

Manufacturer:

SMITH&NEPHEW, INC., ENDOSCOPY DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2021

DAKO Monoclonal Mouse Anti-Human CD246, ALK Protein Clone ALK 1

Manufacturer:

AGILENT TECHNOLOGIES DENMARK APS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

GUERBET Sterile High-Pressure Angiographic Syringes for Single-Use

Manufacturer:

SHENZHEN BOON MEDICAL SUPPLY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

SMITH & NEPHEW Tandem Instruments

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2021

GALLANT™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds

Manufacturer:

ST JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 17, 2021

ENTRANT™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds

Manufacturer:

ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 17, 2021

GENESIS II Knee System

Manufacturer:

SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2021

ZIMMER Dental Instrument Kit System (Sterile)

Manufacturer:

BIOMET 3I DENTAL IBERICA, S.L.U.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2021

SMITH & NEPHEW ANTHEM Total Knee System Instrument

Manufacturer:

WEBER INSTRUMENT GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 19, 2021

FLEX Monoclonal Rabbit Anti-Human Postmeiotic Segregation Increased 2, Clone EP51, Ready-to-Use (Link)

Manufacturer:

AGILENT TECHNOLOGIES, INC. Carpinteria

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2021

AGILIS HISPRO™ Steerable Catheter With Electrodes

Manufacturer:

ST JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2021

FLEX Monoclonal Mouse Anti-Human MutS Protein Homolog 2, Clone FE11, Ready-to-Use (Link)

Manufacturer:

AGILENT TECHNOLOGIES, INC., Carpinteria

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2021

PRISMAFLEX

Manufacturer:

GAMBRO LUNDIA AB

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2021

MIZUHO Operating Table MOT-VE100

Manufacturer:

MIZUHO CORPORATION CHIBA FACTORY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2021

QUADRA ALLURE

Manufacturer:

ST JUDE MEDICAL OPERATIONS (M) SDN BHD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 3, 2021

DAKO PD-L1 IHC 22C3 pharmDx

Manufacturer:

AGILENT TECHNOLOGIES, INC. Carpinteria

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2021

ZIMMER Dental Abutment

Manufacturer:

BIOMET 3I DENTAL IBERICA,S.L.U

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

TRABECULAR METAL Implant

Manufacturer:

BIOMET 3I, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 22, 2021

ZIMMER Dental Instrument Kit System

Manufacturer:

BIOMET 3I DENTAL IBERICA, S.L.U.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 12, 2021

ENGAGE TR ™ Introducer

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2021

ABBOTT Engage™ Introducer

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2021

TAPERED SCREW-VENT and SCREW-VENT Dental Implant System

Manufacturer:

BIOMET 3I, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2020

FemoStop ™ II Plus System Set

Manufacturer:

ST JUDE MEDICAL PUERTO RICO., LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

PRESSUREWIRE™ X Guidewire

Manufacturer:

ST JUDE MEDICAL COSTA RICA LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 20, 2020

PACEL Bipolar Pacing Catheter

Manufacturer:

ST JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2020

PACEL Bipolar Pacing Catheter- Flow Directed

Manufacturer:

ST JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2020

GUERBET Contrast Media Injector Disposables

Manufacturer:

CATHETER RESEARCH, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2020

QUANTIEN Integrated FFR System

Manufacturer:

ST JUDE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2020

DRAGONFLY OPTIS Kit

Manufacturer:

ABBOTT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 5, 2020

OPTISTAR MR Syringe

Manufacturer:

GW PLASTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2020

DAKO FLEX Monoclonal Mouse Anti-Human Cytokeratin 7 Clone OV-TL 12/30 Ready-to-Use (Dako Autostainer / Autostainer Plus)

Manufacturer:

DAKO DENMARK ApS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2020

Envision™ Flex + Mouse (LINKER) (Dako Autostainer/Autostainer Plus)

Manufacturer:

DAKO DENMARK ApS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2020

ILLUMENA Linder-Luer Syringe With Handi-Fil Straw

Manufacturer:

GW PLASTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2020

OPTIVANTAGE Syringe Dual Pack

Manufacturer:

GW PLASTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2020

DAKO FLEX Monoclonal Mouse Anti-Human Estrogen Receptor α Clone 1D5 Ready-to-Use ( Dako Autostainer / Autostainer Plus)

Manufacturer:

DAKO DENMARK ApS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2020

FLEX Polyclonal Rabbit Anti-Human CD3 Ready-to-Use (Dako Autostainer / Autostainer Plus)

Manufacturer:

DAKO DENMARK ApS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2020

CT 9000 ADV Single Head Contrast Delivery System in Computed Tomography

Manufacturer:

LIEBEL - FLARSHEIM COMPANY LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2020

ENVISION™ FLEX Antibody Diluent

Manufacturer:

DAKO DENMARK APS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2020

ENVISION FLEX Mini Kit, High PH (Link)

Manufacturer:

DAKO DENMARK ApS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2020

PRESSUREWIRE™ Receiver

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2020

FAST-CATH™ Hemostasis Introducer

Manufacturer:

ST JUDE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2020

ILUMIEN OPTIS

Manufacturer:

LIGHTLAB IMAGING INC (ABBOTT MEDICAL).

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2020

CARESTREAM Dental Extraoral X-ray System CS 9300 C

Manufacturer:

TROPHY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2020

CARESTREAM CS 3700

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2020

DAKO PT Link 200 and Accessories

Manufacturer:

AGILENT TECHNOLOGIES, LDA, MALAYSIA, SDN.BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2019

DAKO AUTOSTAINER Link 48

Manufacturer:

THERMO SHANDON LIMITED (TRADING AS THERMO FISHER SCIENTIFIC)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2019

CARESTREAM Dental Intraoral Scanner

Manufacturer:

RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2019

FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen Clone MIB-1 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2019

FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin Clone 1A4 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

FLEX Polyclonal Rabbit Anti-S100 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein Clone 124 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

FLEX Monoclonal Mouse Anti-Human p53 Protein Clone DO-7 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

FLEX Monoclonal Mouse Anti-Human Cytokeratin 7 Clone OV-TL 12/30 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

ENGAGE TR ™ Introducer

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2019

RADISTOP ™ Compression Assist Device

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2019

ENGAGE ™ Introducer

Manufacturer:

ST. JUDE MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2019

FLEX Monoclonal Mouse Anti-Human Desmin Clone D33 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2019

FLEX Monoclonal Mouse Anti-Human CD20cy Clone L26 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2019

FLEX Polyclonal Rabbit Anti-Human CD3 Ready-to-Use (Link)

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

DAKO DAB Enhancer

Manufacturer:

DAKO NORTH AMERICA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

DAKO FLEX Monoclonal Mouse Anti-Human CD30 Clone Ber-H2 Ready to use (Link)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

ENVISION FLEX Wash Buffer ( 20x )

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 17, 2019

DAKO FLEX Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05, Ready-to-Use (Link)

Manufacturer:

DAKO NORTH AMERICA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2019

DAKO Monoclonal Mouse Anti-Human CD3 Clone F7.2.38

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2019

DAKO FLEX Monoclonal Mouse Anti-Human CD246, ALK Protein Clone ALK1 Ready to use (Dako Autostainer/Autostainer Plus)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2019

ENVISION FLEX Target Retrieval Solution Low pH ( 50x )

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 13, 2019

DAKO FLEX IHC Microscope Slides, 5 x 10 slides

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 13, 2019

DAKO Monoclonal Mouse Anti-Human CD246, ALK Protein Clone ALK 1

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2019

DAKO ENVISION Flex Hematoxylin ( Link )

Manufacturer:

DAKO DENMARK A/S

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 13, 2019

DAKO FLEX Monoclonal Mouse Anti-Human Cytokerotin 5/6 Clone D5/16 B4 Ready to Use (Dako Autostainer/ Autostainer Plus)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

ENVISION FLEX + Mouse (LINKER) (Link)

Manufacturer:

DAKO NORTH AMERICA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

DAKO FLEX Monoclonal Mouse Anti-Human CD30 Clone Ber-H2 Ready to use (Dako Autostainer/Autostainer Plus)

Manufacturer:

DAKO DENMARK A/S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2019

TENDRIL STS Pacing Lead LPA 1200M

Manufacturer:

ST. JUDE MEDICAL OPERATIONS (M) SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 15, 2019

ALLURE™ RF Cardiac Resynchronization Therapy Device Pulse Generator

Manufacturer:

ST. JUDE MEDICAL PUERTO RICO, LLC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2018

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025