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MEDTRONIC INDONESIA

Authorized Representative in Indonesia

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama
249 Products Represented
89 Manufacturers
Total Products
249
Manufacturers
89
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
19 products
7.6%
Kelas Resiko : B
80 products
32.1%
Kelas Resiko : C
96 products
38.6%
Kelas Resiko : D
54 products
21.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (249)
Complete portfolio registered with BPOM

NG Bio-Medicus Adult Arterial/Internal Jugular Cannula Kits

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

NG BIO-MEDICUS Pediatric Venous Cannula and Introducers

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

AFFINITY CP Centrifugal Blood Pump

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2025

MEDTRONIC Shunt Kits

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC EDM Lumbar

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC Cardiac / Peritoneal Catheters

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC RIALTO INSTRUMENT

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC. Swinnea Road

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 7, 2025

CG Future Sizer Sets

Manufacturer:

MEDTRONIC HEART VALVE DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

MEDTRONIC Lumboperitonial Shunt

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC Ventricular Catheters

Manufacturer:

MEDTRONIC NEUROSURGERY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC Shunt Accessories

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC CSF Valves And Buttons

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC Shunt Assemblies

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

MEDTRONIC Ports And Reservoirs

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

DELTA

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

DLP Disposable Pressure Set

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

BIO-PROBE Disposable Insert- Pediatric DP38P

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

KANGHUI Plate and Screw System Instrument Sets

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 24, 2025

PLASMABLADE

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

AEX Generator

Manufacturer:

SANMINA, HUNTSVILLE, AL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

MEDTRONIC General Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 14, 2025

KANGDI Disposable Circular Stapler for Hemorrhoids

Manufacturer:

CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

STEEL Monofilament Stainless Steel

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

STREAMLINE Unipolar Temporary Myocardial Pacing Wire

Manufacturer:

MEDTRONIC FABRICATION S.A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

STREAMLINE Bipolar Temporary Myocardial Pacing Lead

Manufacturer:

MEDTRONIC FABRICATION S.A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2024

PREMIUM SURGICLIP III Clip Applier 9.0" Small

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

SURGIPRO Monofilament Polypropylene

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2024

SOFSILK Coated Braided Silk

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 11, 2024

MEDTRONIC Integrated Power Console

Manufacturer:

MEDTRONIC XOMED INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2024

NEWPORT™ e360 Ventilator with Accessories, T Model

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

PURITAN BENNETT 560 Ventilator

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

DLP Arteriotomy Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

DLP® Silicone RSCP Cannulae with Manual Inflate Cuff

Manufacturer:

VIANT MEDICAL INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2024

SURGITIE AUTO SUTURE Ligating Loop with Delivery System

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2024

ARISS Perfusion Switch

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 20, 2024

DLP Malleable Single Stage Venous Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 20, 2024

EVOLUT FX Delivery Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 18, 2024

DLP Flexible Arch Arterial Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2024

DLP Aortic Root Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2024

SURE-SNARE Tourniquet Kit

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2024

EVOLUT FX Transcatheter Aortic Valve

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

DLP Curved Tip Arterial Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 12, 2024

MEROGEL® Nasal Dressing/ Sinus Stent and Otologic Packing

Manufacturer:

ANIKA THERAPEUTICS SRL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2024

SHILEY™ Adult Flexible EVAC Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Canula (DIC)

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

WEM Argon Plasma Coagulator

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

SHILEY™ Endobronchial Tube Right

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

SHILEY Adult Flexible EVAC Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (RIC}

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

SHILEY™ Adult Flexible EVAC Tracheostomy Tube with TaperGuard Cuff, Single Cannula (No Inner Cannula)

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

SHILEY™ Endobronchial Tube, Left

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

WEM Microprocessed Electrosurgical Unit Model SS-200E

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2024

COVIDIEN Infant SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

SHILEY Intubating Stylet

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

COVIDIEN NELLCOR Neonatal-Adult SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2024

SHILEY™ Neonatal Tracheostomy Tube Cuffless

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2024

Shiley Endobronchial Tube Left with Carinal Hook

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2024

CD HORIZON Spinal System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2024

SPRINT QUATTRO™ MRI SureScan™ 6946M

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 10, 2024

MEDTRONIC NUVENT EM Sinus Dilation System

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 8, 2024

ABSORBATACK Fixation Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 2, 2024

STRAIGHTSHOT M5 Microdebrider

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 2, 2024

MEDTRONIC Analyzer

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

PERCEPT™ RC INS

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 27, 2024

StrataMR II Valves and Shunt

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

SPIDERFX Embolic Protection Device

Manufacturer:

EV3 INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

ATTAIN Venogram Balloon Catheter

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

MEDTRONIC C315 Delivery Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

VALIANT THORACIC Stent Graft with The Captivia Delivery System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 29, 2024

NITREX Guidewires

Manufacturer:

LAKE REGION MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2024

PACIFIC Plus PTA CATHETER

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2024

CD Horizon Spinal System (Costa Rica)

Manufacturer:

MEDTRONIC MEDICAL COSTA RICA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

LIGASURE IMPACT Curved, Large Jaw, Open Sealer/Divider, Nano-coated

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

EVEREST Disposable Inflation Device

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

CD Horizon Spinal System (Warsaw-Sterile)

Manufacturer:

WARSAW ORTHOPEDIC INC, ALSO KNOWN AS : MEDTRONIC SOFAMOR DANEK MANUFACTURING

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 22, 2024

NanoCross™ Elite PTA Catheter

Manufacturer:

MEDTRONIC INC. (PLYMOUTH)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2024

CD HORIZON Spinal System (2)

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2024

CD HORIZON Solera Spinal System

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2024

CD HORIZON Spinal System (Swinnea)

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2024

Trailblazer™ Support Catheter

Manufacturer:

MEDTRONIC INC. (PLYMOUTH)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2024

VITATRON Q80 DR MRI SureScan™

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

VITATRON G70 DR MRI SureScan™

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

VITATRON G20 SR MRI SureScan G20A2

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

MEDTRONIC Attain Ability Straight

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

VITATRON Q70 DR MRI SureScan™

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

VITATRON Q50 D MRI SureScan™

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

VITATRON Q20 SR MRI SureScan™

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

ONYX™ Liquid Embolic System (LES)

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 24, 2024

SPRINT FOUR

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 24, 2024

SPRINT QUATTRO SECURE S MRI SureScan

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

COMPIA MRI Quad CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 18, 2024

SPRINT QUATTRO SECURE MRI SureScan

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2024

COMPIA MRI CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 14, 2024

TYRX Absorbable Antibacterial Envelope

Manufacturer:

MEDTRONIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

ATTAIN COMMAND + SUREVALVE Left Heart Delivery System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

MEDTRONIC MicroTargeting StarDrive MA

Manufacturer:

FHC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

MEDTRONIC MicroTargeting Star Drive System

Manufacturer:

FHC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 7, 2024

MEDTRONIC OPEN PIVOT Heart Valve

Manufacturer:

MEDTRONIC INC. (MINNEAPOLIS, MN 55447)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 6, 2024

LigaSure ™ XP Maryland Jaw Sealer/Divider

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 1, 2024

REACT™ 68 Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 29, 2024

SERENA ™ Quad CRT-P MRI SureScan ™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 21, 2024

MEDTRONIC Divergence Instrument- Sterile

Manufacturer:

WARSAW ORTHOPEDIC INC, ALSO KNOWN AS : MEDTRONIC SOFAMOR DANEK MANUFACTURING

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2024

GUARDIAN™ Sensor (3)

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 20, 2024

SOLARA™ CRT-P MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 17, 2024

SERENA CRT-P MRI SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 17, 2024

PERCEPTA™ Quad CRT-P MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 17, 2024

ATCERTA™ L DR MRI SureScan™

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE. LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

SPHERA L DR MRI SureScan

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE. LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

PERCEPTA™ CRT-P MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

MEDTRONIC CryoConsole System

Manufacturer:

PLEXUS CORP.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 30, 2024

DBS Lead Kit for Deep Brain Stimulation

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 22, 2024

Micra AV Transcatheter Pacing System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2024

MEDTRONIC SMARTLINK Reusable Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 8, 2024

CLEARVIEW Blower Mister Kit

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2024

BIO-MEDICUS Femoral Arterial Cannula and Introducer

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2023

HANCOCK II Heart Valve (Mitral)

Manufacturer:

MEDTRONIC HEART VALVE

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

TECOMET Universal Removal Screw Instrument

Manufacturer:

TECOMET, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 23, 2023

RAPIDVAC Smoke Evacuator System & Accessories

Manufacturer:

CONSOLIDATED MEDICAL EQUIPMENT COMPANY (CONMED)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

PRESTIGE Anterior Cervical Plate System

Manufacturer:

MEDTRONIC SOFAMOR DANEK MANUFACTURING

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

Ensemble II Transcatheter Valve Delivery System

Manufacturer:

NUMED INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 19, 2023

CAPSTONE® Spinal System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2023

DURAN ANCORE Band with Chordal Guide 620B

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

MYOTHERM XP Cardioplegia Delivery System

Manufacturer:

MEDTRONIC MEXICO S. DE. R.L. DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

Plasmablade™ X 4.0S

Manufacturer:

NEW DEANTRONICS TAIWAN LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2023

Electrical Umbilical Cable

Manufacturer:

THE DOMINICAN GLOBAL ONE

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 4, 2023

Plasmablade™ X 3.0S LIGHT

Manufacturer:

NEW DEANTRONICS TAIWAN LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2023

MIDAS REX Drill System Surgical Dissecting Tools

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

ASCENDA Intratechal Catheter Accessory Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 24, 2023

SHILEY Intubating Stylet

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

MEDTRONIC Open Pivot Heart Valve, 500DM

Manufacturer:

MEDTRONIC, INC. (MINNEAPOLIS)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

SHILEY Spare Inner Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

COVIDIEN WARMTOUCH Convective Warming Unit

Manufacturer:

SANMINA-SCL SYSTEMS (MALAYSIA) SDN BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

ENDO GIA Curved Tip Reload with Tri-Staple Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

ENDO GIA Reloads with Tri-Staple Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

MEDTRONIC OPEN PIVOT Heart Valve, AP Series Model 501DA (Aortic)

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 4, 2023

MEDTRONIC Open Pivot™ Aortic Valved Graft

Manufacturer:

MEDTRONIC INC (Annapolis)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 4, 2023

STRATAVARIUS System and Accessories

Manufacturer:

QUALITEL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2023

MEDTRONIC OPEN PIVOT Heart Valve, Standard Series, Model 500DM (Mitral) ATS Mitral Valve

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 3, 2023

Nucleus Removal Blade

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

NEXT GENERATION BIOMEDICUS Adult Arterial Cannula

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

NEXT GENERATION BIOMEDICUS Pediatric Arterial Cannula

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

Chocolate™ PTA Balloon Catheter

Manufacturer:

EMERALD MEDICAL SERVICES PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

DLP Vessel Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

DLP Aortic Root Cannula with Vent Line

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 16, 2023

DLP Suction Tubes

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 16, 2023

DLP Straight Tip Arterial Cannula-Adult

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2023

AFFINITY PIXIE Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2023

AFFINITY Pediatric Arterial Filter

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

GUNDRY Retrograde Cannula-Manual Inflate

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

KANGHUI OMNAIL FEMORAL NAIL Implant Set

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

CG Future Ring, Model 638R

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

STREAMLINE ™ Unipolar Temporary Atrial Pacing Lead

Manufacturer:

MEDTRONIC FABRICATION S.A.S.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 21, 2023

OCTOBASE™ Retractor System

Manufacturer:

MAX HAUSER SĂśDDEUTSCHE CHIRURGIE MECHANIK GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

TELESCOPE Guide Extension Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

SYMPLICITY G3 Renal Denervation RF Generator

Manufacturer:

PLEXUS CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

LAUNCHER Guiding Catheter

Manufacturer:

MEDTRONIC VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

PROFILE 3D ™ Annuloplasty Ring, Model 680R

Manufacturer:

MEDTRONIC MEXICO S.DE R.L DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

AFFINITY Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

CONTOUR 3D 690R Annuloplasty Ring

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2023

AUTOLOG One Source Pack-ATLS24

Manufacturer:

MEDTRONIC MEXICO S. DE R.L.DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

CG Future Band, Model 638B

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2023

Midas Rex MR8 Drill System Surgical Dissecting Tools

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

OCTOPUS AS Tissue Stabilizer

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2023

STARFISH EVO 3000 Heart Positioner

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2023

THORA TRAK Retractor MICS System

Manufacturer:

KLUGE DESIGN INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2023

Midas Rex Drill System Surgical Dissecting Tools

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

OCTOPUS 4 Tissue Stabilizer

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 17, 2023

OCTOBASE Suture Holding Inserts

Manufacturer:

MAX HAUSER SĂśDDEUTSCHE CHIRURGIE MECHANIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 17, 2023

OCTOPUS® EVOLUTION TISSUE STABILIZER

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 7, 2023

Protégé RX Self-expanding Peripheral and Carotid Stent System

Manufacturer:

EV3, INC.,

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 6, 2023

XPS NEXUS Console

Manufacturer:

JABIL CIRCUIT (SHANGHAI). LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

WHOLEY Guidewire System

Manufacturer:

LAKE REGION MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 20, 2023

INSPIRED ™ O2FLO High Flow Heated Respiratory Humidifier

Manufacturer:

VINCENT MEDICAL (DONGGUAN) TECHNOLOGY COMPANY LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2023

ENT Adhesive Pad

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2023

KANGHUI ECO MIS Minimally Invasive Spine System - Instrument Advance Set-Whole Set

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 7, 2023

Puritan Bennett ™ Cuff Pressure Manager

Manufacturer:

PLEXUS MANUFACTURING SDN, BHD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2023

SLIDE-ON SHEATH FOR SENSORY TESTING

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

SLIDE-ON ENDOSHEATH SYSTEM FOR THE TNE-5000 ESOPHAGOSCOPE

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

Onyx TruCor ™ Zotarolimus-Eluting Coronary Stent System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 1, 2023

Shiley ™ Pediatric Oral/Nasal Endotracheal Tube with Taperguard ™ Cuff, Non DEHP

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2023

SenSight™ Directional Lead Kit B33015

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 16, 2022

KANGHUI CORMATE Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2022

INVOS ™ Infant Regional Saturation Sensor Cerebral/Somatic-Neonatal

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2022

McGRATH MAC Disposable Laryngoscope Blade

Manufacturer:

COVIDIEN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 27, 2022

KANGHUI ECO SWORD Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 8, 2022

HYPERFORM Occlusion Balloon System

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2022

PHENOM Catheter

Manufacturer:

ALEMBIC LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2022

VERSAPORT™ Auto Suture™ Bladed Trocar with Fixation Cannula 5mm

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2022

ENDO GIA™ Reloads with Tri-Staple Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

EEA™ Auto Suture™ Hemorrhoid and Prolapse Stapler with DST Series™ Technology

Manufacturer:

CELESTICA DE MONTERREY S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

VERSAONE™ Fascial Closure System Optical Trocar with Fixation Cannula 12 mm Standard

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 21, 2022

COVIDIEN Endo Clip Auto Suture™ Clip™ Apply

Manufacturer:

CELESTICA DE MONTERREY S.A DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

ENDO GRASP™ AUTO SUTURE™ Grasper 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2022

ENDO SHEARS Auto Suture Shears

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

FORCE FX™ Electrosurgical Generator 8C 240 V

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 13, 2022

ENDO CLINCH™ II AUTO SUTURE™ Grasper 5 mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2022

ENDO CLOSE™ AUTO SUTURE™ Trocar Site Closure Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2022

Cobalt™ XT DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 12, 2022

Cobalt™ DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 8, 2022

Cobalt™ VR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 5, 2022

Cobalt™ VR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 5, 2022

Cobalt™ HF CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 5, 2022

Cobalt™ XT VR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2021

Cobalt™ HF Quad CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2021

Cobalt™ XT VR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 31, 2021

Cobalt™ HF Quad CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 30, 2021

Cobalt™ XT HF CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 30, 2021

Cobalt™ XT HF CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 30, 2021

Cobalt™ XT HF Quad CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 29, 2021

KANGHUI Variloc Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 17, 2021

ATTAIN Select II + SureValve Delivery Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 13, 2021

Concerto™ Detachable Coil System (Nylon)

Manufacturer:

MEDTRONIC MEXICO S. DE R. L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 27, 2021

REVEAL LINQ Insertion Tools

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 19, 2021

MEDTRONIC Extension Tunneling Tool Accessory Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2021

COVIDIEN NELLCOR Adult-Neonatal SpO2 Sensor with Wraps

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2021

CURITY Oral/Nasal Tracheal Tube Cuffed, Murphy Eye

Manufacturer:

COVIDIEN LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

COVIDIEN NELLCOR Pediatric-Infant SpO2 Sensor with Wraps

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

SHILEY Tracheostomy Tube Cuffed with Inner Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

SHILEY Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

CURITY Oral/Nasal Tracheal Tube Cuffless, Murphy Eye

Manufacturer:

COVIDIEN LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

EVERFLEX Self-Expanding Peripheral Stent with Entrust Delivery System

Manufacturer:

EV3 INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 3, 2021

SHILEY Pediatric Tracheostomy Tube Cuffed

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2021

SHILEY Tracheostomy Tube Cuffed with Inner Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2021

PROTEGE RX Self-Expanding Carotid Stent System

Manufacturer:

EV3 INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 25, 2021

COVIDIEN Pump

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2021

VALLEYLAB™ Tungsten Square Loop Electrode

Manufacturer:

BOVIE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

APOLLO ONYX Delivery Micro Catheter

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

COVIDIEN Ligating Clips and Appliers

Manufacturer:

ACKERMANN INSTRUMENTE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2021

PARIETENE Macroporous Mesh

Manufacturer:

SOFRADIM PRODUCTION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2021

COVIDIEN Adult SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2021

AUTO SUTURE Premium Extractor

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 28, 2021

ENDO GRASP™ AUTO SUTURE™ Grasper with Roticulator™ Technology 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2021

VERSAONE Universal Fixation Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2021

ENDO GRASP™ Auto Suture™ Grasper 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2021

COVIDIEN Clearify Visualization Systems

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 21, 2021

ENDO CATCH™ Gold AUTO SUTURE™ Specimen Retrieval Pouch 10mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 21, 2021

ENDO CATCH™ II AUTO SUTURE™ Specimen Retrieval Pouch 15mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

Depth Stop Surgical Dissecting Tools

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2021

MINIMED SURE-T

Manufacturer:

UNOMEDICAL DEVICES S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2020

VERSAONE Optical Trocar with Fixation Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

SURGINEEDLE AUTO SUTURE Insufflation Needle

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

Shiley™ Oral/Nasal Tracheal Tube Cuffless, Non DEHP, Murphy Eye

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

SHILEY Pediatric Tracheostomy Tube Cuffless

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

SHILEY TaperGuard Oral/Nasal Tracheal Tube

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

SHILEY™ Nasal RAE Tracheal Tube Cuffless / Murphy Eye

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

Shiley™ Endobronchial Tube/Left with Carinal Hook

Manufacturer:

MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2020

SHILEY™ Nasal RAE Tracheal Tube Cuffed / Murphy Eye

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2020

SHILEY Lo-Contour Oral/Nasal Tracheal Tube Cuffed/Reinforced, Murphy Eye

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2020

ACHIEVE Mapping Catheter

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2020

ACT Plus-Automated Coagulation Timer

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2020

VersaOne™ Fascial Closure System Reusable Suture Passer

Manufacturer:

ACKERMANN INSTRUMENTE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

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

Last updated: December 2025