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JOHNSON AND JOHNSON INDONESIA TWO

Authorized Representative in Indonesia

Revenue Tower, Lt.27 District 8, SCBD Lot 13 Jl. Jenderal Sudirman Kav. 52-53 Jakarta 12190, Indonesia
304 Products Represented
86 Manufacturers
Total Products
304
Manufacturers
86
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
48 products
15.8%
Kelas Resiko : B
49 products
16.1%
Kelas Resiko : C
193 products
63.5%
Kelas Resiko : D
14 products
4.6%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (304)
Complete portfolio registered with BPOM

ECHELON 3000 60mm Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ECHELON 3000 45mm Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ECHELON 3000 60mm Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ECHELON 3000 60mm Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ECHELON 3000 45mm Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ECHELON 3000 45mm Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ATTUNE All Poly Tibia

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

HARMONIC 700 Shears

Manufacturer:

NPA DE MEXICO S, DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2024

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (Bi-Directional)

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

CORAIL HIP SYSTEM - Corail Revision Femoral Stem

Manufacturer:

VIANT CHAUMONT SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

Actis Duofix Hip Prosthesis

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2024

SURGICEL Endoscopic Applicator

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

CORAIL HIP SYSTEM - Corail Revision Femoral Stem

Manufacturer:

DEPUY IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

Depuy Instrument (WILSEY TOOL COMPANY)

Manufacturer:

WILSEY TOOL COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 27, 2024

PROLENE Polypropylene Suture

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2024

ETHICON MEGADYNE Electrosurgical Generator (Ohio USA)

Manufacturer:

MEGADYNE MEDICAL PRODUCTS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2024

ETHICON MERSILENE Tape

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2024

SURGICEL Absorbable Haemostat

Manufacturer:

ETHICON SARL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

PROLENE Polypropylene Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2024

ETHICON MERSILK Black Silk Braided Non Absorbable

Manufacturer:

JOHNSON & JOHNSON PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2024

PROCEED Surgical Mesh

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2024

PROCEED Ventral Patch

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

ATTUNE Cementless Knee System

Manufacturer:

DEPUY IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2024

ETHICON Hernia Kit

Manufacturer:

JOHNSON & JOHNSON PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2024

VICRYL Absorbable Surgical Suture USP (Synthetic)

Manufacturer:

JOHNSON & JOHNSON PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

MERSILENE Polyester Fiber Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

ETHICON TFE Polymer Pledget

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

PROLENE Polypropylene Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

MERSILK Black Silk Braided Non Absorbable Suture

Manufacturer:

JOHNSON & JOHNSON MEDICAL (CHINA) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 3, 2024

MERSILK-PERMAHAND Braided Silk Non-Absorbable Suture

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 2, 2024

ETHICON Temporary Cardiac Pacing Wire

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

ETHICON Temporary Cardiac Pacing Wire

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

ETHIBOND EXCEL Coated Polyester

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 2, 2024

MERSILK / PERMA-HAND Silk Non-Absorbable Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

ETHIBOND EXCEL Polyester Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

COATED VICRYL POLYGLACTIN 910 SUTURE

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

ENDOLOOP Ligature made with PDS II (Polydioxanone) Suture

Manufacturer:

JOHNSON & JOHNSON OF BRAZIL IND. COM. OF PROD. P/HEALTH LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

SURGICEL Endoscopic Applicator

Manufacturer:

ALLTRISTA PLASTICS LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

ULTRAPRO ADVANCED Macroporous Partially Absorbable Mesh

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2024

DePuy Instrument (DEPUY ORTHOPAEDICS)

Manufacturer:

DEPUY ORTHOPAEDICS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 23, 2024

Depuy Instrument (PARAGON MEDICAL INC)

Manufacturer:

PARAGON MEDICAL INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 23, 2024

ETHICON Caesar Kit

Manufacturer:

JOHNSON & JOHNSON PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

ETHICON Surgical Stainless Steel Suture

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

ETHICON Surgical Stainless Steel Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

ETHICON Abhy Kit

Manufacturer:

JOHNSON & JOHNSON PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

ETHIBOND EXCEL Polyester Suture

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

ETHILON Nylon Suture

Manufacturer:

ETHICON, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 17, 2024

STRATAFIX Spiral PGA-PCL Knotless Tissue Control Device (Bi-Directional)

Manufacturer:

SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

ETHILON Nylon Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

ETHICON Nylon Tape

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

ULTRAPRO Mesh

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2024

WEBSTER Duo-Decapolar Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 2, 2024

NAVISTAR Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 1, 2024

ETHILON Polyamide 6 Monofilament

Manufacturer:

JOHNSON & JOHNSON PRIVATE LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 1, 2024

ETHILON Nylon Suture

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 28, 2024

ENDOLOOP Ligature made with PDS II (Polydioxanone) Suture

Manufacturer:

JOHNSON & JOHNSON DO BRASIL IND. COM. DE PROD. P/ SAUDE LTDA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 28, 2024

ULTRAPRO PLUG

Manufacturer:

JOHNSON & JOHNSON INTERNATIONAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

ETHICON PHYSIOMESH OPEN Flexible Composite Mesh Device

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

EZ STEER Bi-Directional Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 26, 2024

WEBSTER Electrophysiology Catheter (Fixed Curved)

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 19, 2024

HALO XP Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2024

STRATAFIX Spiral PDO Knotless Tissue Control Device (Bi-Directional)

Manufacturer:

SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2024

Ethicon SECURESTRAP 55mm Absorbable Strap Fixation Device

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2024

ETHICON SECURESTRAP Open Absorbable Strap Fixation Device

Manufacturer:

ETHICON, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 14, 2024

LASSO 2515 NAV Eco VARIABLE Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 8, 2024

HARMONIC Blue Hand Piece

Manufacturer:

NPA DE MEXICO S. DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2024

HARMONIC Hand Piece

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2024

HARMONIC Hand Piece

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

HARMONIC Blue Hand Piece

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 13, 2024

OPTRELL Mapping Catheter with TRUEref Technology

Manufacturer:

BIOSENSE WEBSTER, INC, MEXICO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 13, 2024

PENTARAY NAV Eco High Density Mapping Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 13, 2024

ETHICON Endo Surgery Generator G11

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2024

BIOSENSE WEBSTER CARTO 3 EP Navigation System

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2024

CARTO 3 System External Reference Patches

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2024

CARDIOTEK EP TRACER 70

Manufacturer:

CARDIOTEK B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

CARDIOTEK EP TRACER 102

Manufacturer:

CARDIOTEK B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

CARTO VIZIGO BI-DIRECTIONAL GUIDING SHEATH

Manufacturer:

FREUDENBERG MEDICAL LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2024

Depuy Instrument (SYNTHES PRODUKTIONS GMBH)

Manufacturer:

SYNTHES PRODUKTIONS GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 20, 2024

THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 5, 2024

THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

MEMORYGEL Smooth Round Xtra Gel Breast Implant

Manufacturer:

MENTOR MEDICAL SYSTEMS B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

DERMABOND Topical Skin Adhesive

Manufacturer:

ETHICON LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

CARTO OCTARAY Mapping Catheter with TRUEref Technology

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

NAVISTAR Thermocool Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

DERMABOND PRINEO Skin Closure System

Manufacturer:

ETHICON LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

DERMABOND ADVANCED Topical Skin Adhesive

Manufacturer:

ETHICON LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

ENDOPATH XCEL Trocar

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

LASSO NAV eco CATHETER

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

CELSIUS FLTR Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

DERMABOND Propen Topikal Skin Adhesive

Manufacturer:

ETHICON LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

LASSO Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

SOUNDSTAR 3D Diagnostic Ultrasound Catheter

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2023

CELSIUS Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

SOUNDSTAR Eco Diagnostic Ultrasound Catheter

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

ENDOPATH XCEL Trocar Dilating Tip with Optiview

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2023

DECANAV Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

Celsius DS Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

Celsius Thermocool Electrophysiology Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

CELSIUS FLTR Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 20, 2023

ENDOPATH XCEL Blunt Tip Trocar with Optiview Technology

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

DEPUY Instrument (GREATBATCH MEDICAL)

Manufacturer:

GREATBATCH MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 18, 2023

THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter

Manufacturer:

BIOSENSE WEBSTER, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2023

SIGMA Knee System (Johnson & Johnson Medical Suzhou)

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

SIGMA Knee System

Manufacturer:

DEPUY IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

ENDOPATH Dextrus Seal Cap Assembly

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2023

ENDOPATH 5mm and 10mm Diameter Endoscope Instrument

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

ENDOPATH Dextrus Fixed Length Access Retractors

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

ETHICON Endopath Bipolar Forceps

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 23, 2023

PROXIMATE Reloadable Linear Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2023

LIGACLIP Clip Appliers

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 23, 2023

ENDOPATH Endoscopic Needle Holder

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 23, 2023

ETHICON ENDO-SURGERY Endoscopic Curved Intraluminal Stapler (ILS)

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2023

LIGACLIP MCA Multiple Clip Applier

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2023

ETHICON Circular Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2023

LIGACLIP Clip Appliers

Manufacturer:

POST SURGICAL MANUFACTURING INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2023

HARMONIC ACE+7 Shears with Advanced Hemostasis

Manufacturer:

ETHICON ENDO-SURGERY S.A DE C.V PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2023

ECHELON FLEX Powered Plus Compact Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

LIGACLIP Extra Ligating Clips

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

ENDOPATH Electrosurgery Probe Plus II

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

Depuy Instrument (TECH NH INC USA)

Manufacturer:

TECH NH INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

LIGACLIP MCA Multiple Clip Applier

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

LIGACLIP Endoscopic Rotating Multiple Clip Applier

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

Depuy Instrument (CLARO PRECISION ENGINEERING LTD, UK)

Manufacturer:

CLARO PRECISION ENGINEERING LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

Depuy Instrument (HAVEN MFG INDIANA USA)

Manufacturer:

HAVEN MFG INDIANA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

HARMONIC ACE Shears + Adaptive Tissue Technology

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

ENDOPATH Purse String Clamp

Manufacturer:

JOHNSON & JOHNSON MEDICAL GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

ENDOPATH Electrosurgery Probe Plus II

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

ENDOPATH ECHELON Vascular White Reload for Advanced Placement Tip

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

LIGACLIP Endoscopic Rotating Multiple Clip Applier

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

ETHICON ENDO-SURGERY Linear Cutter 55/75mm and Selectable Cartridge/Reloads

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 4, 2023

ECHELON FLEX 60 Powered Plus Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2023

ECHELON Flex 45 Endopath Stapler Compact Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2023

LIGAMAX 5mm Endoscopic Multiple Clip Applier

Manufacturer:

NPA DE MEXICO S. DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

LIGAMAX 5mm Endoscopic Multiple Clip Applier

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE. C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 31, 2023

HARMONIC Gray Hand Piece

Manufacturer:

NPA DE MEXICO S. DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

HARMONIC Blue Hand Piece

Manufacturer:

ETHICON ENDO-SURGERY, S.A., DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

HARMONIC SYNERGY Combination Hook Blade with Torque Wrench

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

PROXIMATE PPH

Manufacturer:

ETHICON ENDO-SURGERY, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

HARMONIC Blue Hand Piece

Manufacturer:

NPA DE MEXICO S. DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

STOCKERT SMARTABLATE Irrigation Pump

Manufacturer:

STOCKERT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

ENDOPATH BASX Stability Sleeves

Manufacturer:

ETHICON ENDO-SURGERY S.A DE C.V PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

ETHICON ENDO-SURGERY Curved and Straight Intraluminal Stapler (ILS)

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

HARMONIC FOCUS Shears + Adaptive Tissue Technology

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

ECHELON FLEX 60 Endopath Stapler Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

HARMONIC HD1000i Shears

Manufacturer:

NPA DE MEXICO S. DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

HARMONIC FOCUS Long Shears + Adaptive Tissue Technology

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

HARMONIC FOCUS Shears + Adaptive Tissue Technology

Manufacturer:

ETHICON ENDO-SURGERY S.A DE C.V PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

ENDOPATH BASX Bladeless Trocars with Stability Sleeves

Manufacturer:

ETHICON ENDO-SURGERY S.A DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

ECHELON Contour GST Reload

Manufacturer:

NYPRO HEALTHCARE BAJA, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

ECHELON FLEX Powered Plus Long Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

ECHELON FLEX Powered Plus Compact Articulating Endoscopic Linear Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

HARMONIC 1100 Shears

Manufacturer:

NPA DE MEXICO S. DE R.L DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

ECHELON CIRCULAR Powered Staplers

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

ECHELON Contour Curved Cutter

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2023

ECHELON 45 Endopath Stapler Endoscopic Linear Cutter Reloads

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

ECHELON FLEX 60 Powered Endopath Stapler

Manufacturer:

NYPRO HEALTHCARE BAJA INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

ACUSON ACUNAV Diagnostic Ultrasound Catheter

Manufacturer:

SIEMENS HEALTHINEERS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

ILS Circular Sizer Set

Manufacturer:

ETHICON ENDO-SURGERY, LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 6, 2023

ETHICON HARMONIC HD 1000i Shears

Manufacturer:

ETHICON ENDO-SURGERY S.A DE C.V PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 5, 2023

ENSEAL X1 Tissue Sealers

Manufacturer:

ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 5, 2023

PINNACLE GRIPTION Acetabular Shell

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

CORAIL HIP SYSTEM - Corail Revision Femoral Stem

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2023

CORAIL HIP System - Cemented Femoral Stem

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2023

CORAIL Hip System - Corail AMT

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2023

SMARTABLATE RF Generator System

Manufacturer:

STOCKERT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

TECNIS PureSee™ IOL with TECNIS Simplicity™ Delivery System

Manufacturer:

AMO GRONINGEN B.V.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2023

SIGMA Knee System

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

HARMONIC FOCUS Long Shears + Adaptive Tissue Technology

Manufacturer:

ETHICON ENDO-SURGERY S.A DE C.V. PLANTA II

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

ELITE PLUS Femoral Head

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2023

PROXIMATE Linear Cutter and Reload

Manufacturer:

NYPRO HEALTHCARE BAJA INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2023

ARTICUL/EZE Femoral Head

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2023

SOLUTION SYSTEM

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2023

Depuy Instrument (IN'TECH MEDICAL SA FRANCE)

Manufacturer:

IN'TECH MEDICAL SA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 20, 2023

PINNACLE Cancellous Bone Screw

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2023

ELITE PLUS System

Manufacturer:

DEPUY INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2023

SMARTSET GHV Gentamicin Bone Cement

Manufacturer:

DEPUY INTERNATIONAL LIMITED T/A DEPUY CMW

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 16, 2023

PINNACLE MARATHON Polyethylene Acetabular Liner

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 16, 2023

ENSEAL X1 Large Jaw Tissue Sealer

Manufacturer:

NPA DE MEXICO S.DE R.L. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2023

DEPUY Hardinge Cement Restrictor

Manufacturer:

DEPUY INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

DEPUY Modular Endo Heads

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

DEPUY Titanium Roof Pile Screw

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

DEPUY Hardinge Cement Restrictor

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2023

C-STEM Total Hip System

Manufacturer:

DEPUY INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

SUMMIT Tapered Hip System

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

PINNACLE Acetabular Cup System

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

ARTICUL/EZE Femoral Head

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

SUMMIT Femoral Cemented Stem

Manufacturer:

JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

P.F.C Sigma Knee System

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

GLOBAL FX The Shoulder Fracture System

Manufacturer:

DEPUY ORTHOPEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

SmartSet GHV Gentamicin Bone Cement

Manufacturer:

DEPUY INTERNATIONAL LIMITED T/A DEPUY CMW

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

PFC Sigma Knee System

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

PINNACLE BIOLOX Delta Ceramax Ceramic Insert

Manufacturer:

CERAMTEC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

DEPUY CMW 3 Gentamicin Bone Cement

Manufacturer:

DEPUY INTERNATIONAL LIMITED T/A DEPUY CMW

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

DEPUY CMW 3 Gentamicin Bone Cement

Manufacturer:

DEPUY INTERNATIONAL LTD T/A DEPUY CMW

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

GLOBAL FX The Shoulder Fracture System

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

ETHICON Circular Sizer

Manufacturer:

DSC (DESIGN STANDARDS CORP.)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2023

PINNACLE Instrument

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 2, 2023

SYNTHES UNIUM System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

PROTRUSIO Cage

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2023

Syringe Kit

Manufacturer:

DEPUY INTERNATIONAL LIMITED T/A DEPUY CMW

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 30, 2023

SYNTHES Trauma Recon System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2023

MORELAND System

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 29, 2023

SYNTHES COMPACT Air Drive II System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

DEPUY Protrusio Cage Trial

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2023

DEPUY Metal on Metal Femoral Head

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2023

DEPUY Metal on Metal Femoral Head

Manufacturer:

DEPUY INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2023

DEPUY Pinnacle Acetabular Cup System

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2023

DEPUY CMW Syringe Kit

Manufacturer:

DEPUY INTERNATIONAL LIMITED, T/A DEPUY CMW

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 24, 2023

SYNTHES COLIBRI II System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 24, 2023

DEPUY CMW 3 Bone Cement

Manufacturer:

DEPUY INTERNATIONAL LIMITED T/A DEPUY CMW

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

SYNTHES Battery Reamer/Drill II System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

C-STEM™ AMT

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

ATTUNE Knee System

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

DEPUY PRESERVATION UNI Knee Mobile Bearing Tibial

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

SYNTHES Battery Oscillator II System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

SYNTHES Battery Reciprocator II System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

DEPUY Pinnacle Cancellous Bone Screws

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 17, 2023

CMW MK III Cement Gun

Manufacturer:

KIRKSTALL PRECISION, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 17, 2023

SYNTHES VA-LCP System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 17, 2023

SYNTHES Air Pen Drive System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

SYNTHES VA-LCP Elbow System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2023

SYNTHES Plate System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2023

ATTUNE Knee System

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2023

SYNTHES Wire System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

SYNTHES Drill Bit

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 11, 2023

SYNTHES Screw System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2023

SYNTHES VA - LCP Elbow System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2023

SYNTHES VA - LCP System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2023

SYNTHES PFNA System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2023

nGen Pump

Manufacturer:

STELLARTECH RESEARCH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 2, 2023

SYNTHES Instrument System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2023

ATTUNE Revision Knee System

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2023

SYNTHES LCP System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2023

SYNTHES Cutting Tools

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 31, 2023

MAXFRAME Multi-Axial Correction System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 28, 2023

ELITA™ Femtosecond Laser System

Manufacturer:

AMO MANUFACTURING USA, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 28, 2023

SYNTHES Locking Calcaneal Plate System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 28, 2023

SYNTHES DCP System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2023

ZERO-P

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2023

SYNTHES Locking Distal Radius System 2.4

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2023

ANSPACH eMax 2 Plus Handpiece

Manufacturer:

THE ANSPACH EFFORT, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 24, 2023

Attune Knee System

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2023

SYNTHES Expert Nailing System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 20, 2023

SYNTHES Electric Pen Drive System

Manufacturer:

SYNTHES GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

ANSPACH Emax 2 Plus System

Manufacturer:

THE ANSPACH EFFORT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

SYNTHES Fixator System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2023

Depuy Instrument (Lincotek Medical USA)

Manufacturer:

LINCOTEK MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 17, 2023

SYNTHES Chisel and Impactor Set

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 13, 2023

SYNTHES DHS/DCS System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2023

DePuy Instrument (Nemcomed)

Manufacturer:

NEMCOMED LLC., (DBA AVALIGN INSTRUMENTS AND IMPLANTS)

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 9, 2023

Depuy Instrument (Johnson & Johnson Medical Suzhou)

Manufacturer:

JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 9, 2023

DePuy Instrument (ARCH Medical)

Manufacturer:

ARCH MEDICAL SOLUTIONS - SEABROOK, LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 6, 2023

DePuy Instrument (Intech Medical)

Manufacturer:

INTECH MEDICAL SAS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 6, 2023

DePuy Instrument

Manufacturer:

PERRYMAN COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 4, 2023

SYNTHES Nail System

Manufacturer:

SYNTHES GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2023

MARATHON XLPE Cemented Cup

Manufacturer:

DEPUY INTERNATIONAL LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2023

PHILOS System

Manufacturer:

SYNTHES GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2023

SYNTHES Plate System 2

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2023

SYNTHES SynReam Reaming System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2023

SYNTHES Plate System 3

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2023

DEPUY Cement Restrictor

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 23, 2023

ALTRX Acetabular Liner

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

ACTIS DUOFIX Hip Prosthesis

Manufacturer:

DEPUY ORTHOPAEDIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

SYNTHES Screw System 2

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2023

SYNTHES Expert Nailing System 2 (Non Sterile)

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2023

SYNTHES Plate System 4

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2023

DEPUY PFC SIGMA RPF Knee System

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2023

TRI-LOCK BPS

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 13, 2023

TECOMET Instrument System

Manufacturer:

TECOMET INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 9, 2023

DePuy Instrument (Scientific Molding)

Manufacturer:

SCIENTIFIC MOLDING CORP LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 9, 2023

DePuy Instrument (NG Instruments)

Manufacturer:

NG INSTRUMENTS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 7, 2023

SYNTHES Screw System 3

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2023

PINNACLE GVF Constrained Liner

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2023

C-STEM AMT

Manufacturer:

DEPUY INTERNATIONAL LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2023

DEPUY Canal Reamer

Manufacturer:

DEPUY ORTHOPAEDICS INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2023

DEPUY Instrument (Norwood Medical)

Manufacturer:

NORWOOD MEDICAL

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2023

DEPUY Instrument (Mack Molding)

Manufacturer:

MACK MOLDING COMPANY

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 1, 2023

SIGMA TC3

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 29, 2023

ACCURATUS Instrument System

Manufacturer:

ACCURATUS AG

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 29, 2023

ANSPACH eG1 High Speed System

Manufacturer:

THE ANSPACH EFFORT INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2023

DEPUY Instrument

Manufacturer:

ORCHID ORTHOPAEDIC SOLUTIONS, CHELSEA LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 25, 2023

ATTUNE Cementless Knee System

Manufacturer:

DEPUY (IRELAND)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2023

MEGADYNE™ Smoke Evacuator

Manufacturer:

MEGADYNE MEDICAL PRODUCTS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2023

Sigma HP Instrument

Manufacturer:

DEPUY ORTHOPAEDICS, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2023

MEGA TIP

Manufacturer:

ETHICON INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 4, 2023

SYNTHES TFNA Proximal Femoral Nailing System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

MULTILOC Humeral Nailing System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

TOMOFIX System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissector

Manufacturer:

NEW DEANTRONICS TAIWAN, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

SYNTHES Femoral Recon Nail System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 26, 2023

SYNTHES Reamer Irrigator Aspirator (RIA) System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 25, 2023

SYNTHES Femoral Neck System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2023

SYNTHES SYNFRAME System

Manufacturer:

SYNTHES GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 17, 2023

ENZTEC Sigma HP Instrument

Manufacturer:

ENZTEC LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 6, 2023

1-DAY ACUVUE® DEFINE® Brand Contact Lenses with LACREON®

Manufacturer:

JOHNSON & JOHNSON VISION CARE IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2022

ACUVUE® OASYS Brand Contact Lenses with HydraLuxe®

Manufacturer:

JOHNSON & JOHNSON VISION CARE IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2022

1-DAY ACUVUE® MOIST Brand Contact Lenses for ASTIGMATISM with LACREON®

Manufacturer:

JOHNSON & JOHNSON VISION CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2022

1-DAY ACUVUE® MOIST Brand Contact Lenses with LACREON®

Manufacturer:

JOHNSON & JOHNSON VISION CARE IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2022

1-DAY ACUVUE® MOIST Brand Contact Lenses for ASTIGMATISM with LACREON®

Manufacturer:

JOHNSON & JOHNSON VISION CARE IRELAND UC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2022

1-DAY ACUVUE® MOIST Brand Contact Lenses with LACREON®

Manufacturer:

JOHNSON & JOHNSON VISION CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2022

1-DAY ACUVUE® MOIST Brand MULTIFOCAL Contact Lenses with LACREON®

Manufacturer:

JOHNSON & JOHNSON VISION CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 21, 2022

ACUVUE® OASYS Brand Contact Lenses with HydraLuxe® for ASTIGMATISM

Manufacturer:

JOHNSON & JOHNSON VISION CARE, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2022

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

Last updated: December 2025