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PT. 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
786 Products Represented
212 Manufacturers
Total Products
786
Manufacturers
212
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
65 products
8.3%
Kelas Resiko : B
200 products
25.4%
Kelas Resiko : C
366 products
46.6%
Kelas Resiko : D
155 products
19.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (786)
Complete portfolio registered with BPOM

BIS™ Advance Monitor

Manufacturer:

JABIL CIRCUIT SINGAPORE PTE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2025

ATLANTIS Anterior Cervical Plate System

Manufacturer:

MEDTRONIC SOFAMOR DANEK MANUFACTURING

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 12, 2025

DLP Retrograde Cannula-Auto Inflate-PVC Body

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 12, 2025

BIO-MEDICUS Pediatric Arterial Cannula & Obturator

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

BIO-MEDICUS Pediatric Insertion Kit

Manufacturer:

MEDTRONIC MEXICO S.DE R.L.DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

BIOMEDICUS Percutaneous Kit, Multi Stage Veneous Femoral

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2025

EDM Catheters

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2025

EXACT

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2025

STARFISH NS Heart Positioner

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 8, 2025

NEO Supra Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 7, 2025

V-LOC™ PBT Non-Absorbable Wound Closure Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2025

TRI-AD 2.0 Adams Tricuspid Band

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

CD HORIZON Spinal System

Manufacturer:

MEDTRONIC SOFAMOR DANEK MANUFACTURING

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2025

APPOSE ULC Auto Suture Slim Body Skin Stapler

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

ENDO GIA Ultra Universal Stapler

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

COVIDIEN Plain Gut Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

DLP Single Stage Venous Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

NG BIO-MEDICUS ™ Adult Venous Cannula and Introducer

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

BIOSYN™ Monofilament Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2025

FUSION COMPACT™ ENT NAVIGATION SYSTEM

Manufacturer:

MEDTRONIC NAVIGATION, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

KANGHUI Implant Spine

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 30, 2025

MEDTRONIC StealthStation S7 Navigation System

Manufacturer:

MEDTRONIC NAVIGATION INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

MEDTRONIC Integrated Power Console (IPC) NT

Manufacturer:

MEDTRONIC XOMED, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

MEDTRONIC XPS StraightShot M4 Microdebrider

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

AQUAMANTYS Sealer

Manufacturer:

NEXTPHASE MEDICAL DEVICES LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

NEWPORT ™ Ventilator with Accessories

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

NEWPORT ™ e360 Ventilator with Accessories, S Model

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

VALLEYLAB ™ FT10 Electrosurgical Generator

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2025

STREAMLINE Unipolar Temporary Myocardial Pacing Lead

Manufacturer:

MEDTRONIC FABRICATION S.A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

PROTEGE RX Self-expanding Carotid Stent System

Manufacturer:

MEDTRONIC INC. (PLYMOUTH)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 13, 2025

X-PEDION Hydrophilic Guidewire

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2025

VALLEYLAB ™ FT10 Vessel Sealing Generator

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2025

MIRAGE ™ .008 Hydrophilic Guidewire

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2025

SOFSILK ™ Wax or Silicone Coated Braided Silk

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 7, 2025

POLYSORB Braided Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 7, 2025

KANGHUI Variloc Pelvic Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 6, 2025

STEEL Monofilament Stainless Steel

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 6, 2025

AVALUS Bioprothesis Model 400

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2025

MEDTRONIC PSO Reusable Instruments

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC. SWINNEA ROAD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 2, 2025

AUTOLOGOUS IQ™

Manufacturer:

PLEXUS MANUFACTURING SDN,BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2025

ENDO SHEARS ™ Auto Suture ™ Shears

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

BIOSYN ™ Monofilament Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

NOVAFIL Monofilament Polybutester

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

POLYSORB ™ Braided Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2024

SELECT SERIES Angled Tip Arterial Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 24, 2024

SURGIPRO Monofilament Polypropylene

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2024

EEA AUTO SUTURE Circular Stapler with DST Series Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2024

BIS Complete Monitoring System

Manufacturer:

JABIL CIRCUIT SINGAPORE PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

DLP Straight Tip Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2024

MINIMED RESERVOIR

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

MEDTRONIC Probe

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

MAXON Monofilament Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2024

ENDO GIA ™ Radial Reload with Tri-Staple Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2024

GIA AUTO SUTURE Loading Unit with DST Series Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2024

PURITAN BENNETT ™ 840 Ventilator System

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

NEWPORT ™ HT70 Plus Ventilators

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

CELESTICA Electroencephalograph Electrode

Manufacturer:

CELESTICA ELECTRONICS (S) PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2024

PROTACK AUTO SUTURE Fixation Device 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

MEDTRONIC Refill Kit

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2024

NELLCOR™ Bedside SpO2 Patient Monitoring System

Manufacturer:

MEDIAN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2024

COVIDIEN Nellcor™ SpO2 Module, Interface Cable Included

Manufacturer:

JABIL CIRCUIT SINGAPORE PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2024

Nellcor™ Bedside Respiratory Patient Monitoring System

Manufacturer:

COVIDIEN IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2024

RELIANT Button Switch Pencil Holster

Manufacturer:

NEW DEANTRONICS TAIWAN, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

VALLEYLAB™ Rocker and Button Switch Pencil Holster

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

VALLEYLAB Electrosurgical Return Electrodes

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

MAXON ™ Monofilament Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2024

SPECIFY SURESCAN MRI 2X8 Lead Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 20, 2024

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

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

EDGE ™ Rocker and Button Switch Pencil Holster

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

ENDO CLIP™ III Auto Suture™ Clip Applier with Clip Logic™ Technology 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2024

MEDTRONIC Catheter Access Port Kit

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2024

OCTOPUS NUVO Tissue Stabilizer

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2024

MIAR Aortic Root Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2024

VALLEYLAB Bayonet Forceps

Manufacturer:

KIRWAN SURGICAL PRODUCTS LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2024

COVIDIEN Pediatric SomaSensor®

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2024

COVIDIEN OxyAlert NIRSensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2024

DLP Left Heart Vent Catheter

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 12, 2024

MEDTRONIC MYCARELINK SMART Patient Reader

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2024

MICRA™ VR2

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

MICRA™ AV2

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

MEDTRONIC MRC Reusable Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA., INC. SWINNEA ROAD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2024

MEDTRONIC SEXTANT II Reusable Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 31, 2024

VECTRIS 1x8 Subcompat Trial Lead

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 30, 2024

WEM Microprocessed Electrosurgical Unit Model SS-501SX

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2024

MEDTRONIC TRIMLINE Reuseable Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 29, 2024

MAST QUADRANT Retractor System

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC. Swinnea Road

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 29, 2024

BE-ST Pedicle Access Needle

Manufacturer:

LACEY MANUFACTURING CO., LLC. DBA BOSTON ENDO SURGICAL TECHNOLOGIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2024

DAR Guedel Airway

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2024

Evolut FX Loading System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

MEDTRONIC Communicator

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2024

ATTAIN Stability Quad MRI SureScan 4798

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2024

MEDTRONIC Lead End Cap Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2024

MEDTRONIC Pin Plug Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO, VILLALBA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2024

CAPSUREFIX NOVUS

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 10, 2024

MEDTRONIC Dual Chamber Temporary External Pacemaker

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 10, 2024

V-LOC™ 90 Absorbable Wound Closure Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

KANGHUI OMNAIL FEMORAL NAIL Instrument Set

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 9, 2024

MEDTRONIC Patient Connector

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

MIRRO MRI DR SURESCAN DDME3D1

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2024

CAPSURE SENSE MRI SURESCAN Lead

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 2, 2024

ENDURANT II Stent Graft System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 2, 2024

MEDTRONIC Adjustable Slitter

Manufacturer:

MEDTRONIC, INC, MOUNDS VIEW.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 1, 2024

REVEAL LINQ Insertable Cardiac Monitor

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

NANOCROSS Elite 0.014

Manufacturer:

EV3 INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

PROTEGE GPS Self-expanding Peripheral Stent

Manufacturer:

EV3, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

TRAILBLAZER Support Catheter

Manufacturer:

EV3 INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

PROTEGE™ GPS™ Self-expanding Peripheral Stent System

Manufacturer:

MEDTRONIC INC. (PLYMOUTH)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 20, 2024

REVEAL LINQ ™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

CAPSTONE SPINAL SYSTEM

Manufacturer:

MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2024

MEDTRONIC Patient Programmer TH91D

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 10, 2024

CAPSTONE PTC ™ SPINAL SYSTEM

Manufacturer:

MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2024

FLEXCATH ADVANCE ™

Manufacturer:

MEDTRONIC CRYOCATH LP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2024

VALLEYLAB FT10 FT Series Energy Platform

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 27, 2024

SHILEY Lo-Contour Oral/Nasal Tracheal Tube Cuffed/ Reinforced

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 27, 2024

ENDO CLIP II AUTO SUTURE Clip Applier 10mm Medium/ Large

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

ACHIEVE ADVANCE Mapping Catheter

Manufacturer:

LAKE REGION MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

DxTERITY Diagnostic Angiography Catheter

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

PURITAN BENNETT 980 Ventilator

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

MEDTRONIC Catheter Connecting Cable

Manufacturer:

CEA MEDICAL MANUFACTURING, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

EXPORT ADVANCE Aspiration Catheter

Manufacturer:

MEDTRONIC VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2024

MCGRATH MAC Video Laryngoscope

Manufacturer:

PLEXUS ELECTRONICA S, DE R.L. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 31, 2024

AURORA EV-ICD™ MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE SARL

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 29, 2024

MEDTRONIC Nitron CryoConsole™

Manufacturer:

COVIDIEN

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 29, 2024

INVOS Adult rSO2 Sensor and Accessories

Manufacturer:

CELESTICA ELECTRONICS (S) PTE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2024

CONTEGRA™ 200 Pulmonary Valved Conduit

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 5, 2024

CLOSUREFAST Endovenous Radiofrequency Ablation (RFA) Catheter

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

VALLEYLAB FX8 FX Series Energy Platform

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2024

EEA Circular Stapler with Tri-Staple Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2024

GAUTHIER Orthopedic Manual Surgical Instrument - 1

Manufacturer:

GAUTHIER BIOMEDICAL, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 19, 2024

MEDTRONIC Tunneling Tool

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 19, 2024

COVIDIEN Single Incision Laparoscopic Surgery (SILS)

Manufacturer:

CELESTICA DE MONTERREY S.A. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

GAUTHIER Orthopedic Manual Surgical Instrument - 2

Manufacturer:

GAUTHIER BIOMEDICAL, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 12, 2024

MEDTRONIC Reusable Instrument & Accessories

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 7, 2024

CD HORIZON Spinal System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2024

CD Horizon Spinal System (Warsaw)

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2024

IN. PACT ADMIRAL Paclitaxel-coated PTA Balloon Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

MICROMAR EasyDrill Cranial Perforator

Manufacturer:

MICROMAR INDUSTRIA E COMERCIO LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

ABRE Venous Self-expanding Stent System

Manufacturer:

MEDTRONIC INC

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 24, 2024

EVERA MRI S VR SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2024

MEDTRONIC Manual Retraction Kit

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2024

PRIMO MRI™ VR SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

PRIMO MRI™ VR SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

MIRRO MRI DR SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

MIRRO MRI™ VR SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

PRIMO MRI™ DR SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

MEDTRONIC Mirro MRI VR SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

PRIMO MRI™ DR SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

CAPSUREFIX NOVUS

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

CAPSURE ™ EPI

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

MEDTRONIC CapSure Sense MRI SureScan

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

MICRA Introducer Sheath with Hydrophilic Coating

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

MEDTRONIC Attain Ability Plus

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

MEDTRONIC Attain Performa

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2024

MEDTRONIC Reusable Instrument & Accessories (Warsaw)

Manufacturer:

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

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 24, 2024

MEDTRONIC Patient Connector

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 19, 2024

SPRINT QUATTRO SECURE

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 18, 2024

SPRINT QUATTRO SECURE S

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 18, 2024

ATTAIN ABILITY

Manufacturer:

MEDTRONIC PUERTORICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 18, 2024

MEDTRONIC Reusable Instrument & Accessories (Puerto Rico)

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO, HUMACAO

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2024

COVIDIEN NELLCOR Adult SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2024

ATTAIN COMMAND ™ + SureValve ™ Guide Catheter for Left Heart Delivery

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

Solitaire ™ X Revascularization Device

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 7, 2024

COMPIA MRI CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 6, 2024

ENDURANT ™ IIs Stent Graft System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 6, 2024

REACT™ 71 Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 4, 2024

ENDURANT™ II Stent Graft System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 1, 2024

MEDTRONIC Extension Accessory Kit (SCS)

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

MEDTRONIC Orthopedic Manual Surgical Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 27, 2024

SOLARA ™ 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

ACTIVE SC

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 17, 2024

ACTIVATE PC

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 17, 2024

DAR HME for Tracheostomized Patients

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2024

DAR Electrostatic Filter

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2024

MEDTRONIC Micra MC1VR01 Transcatheter Pacing System

Manufacturer:

MEDTRONIC IRELAND.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

MEDTRONIC DBS Tunneling Tool Accessory Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

SPHERA SR MRI SureScan

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE. LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

AFFINITY AF 100 Arterial Filter with Balance Biosurface

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2024

ELEVISION HD 2 CCU Image and Video REC

Manufacturer:

SCHOLLY FIBEROPTIC, GMBH.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2024

ADJUSTABLE Valve 6248VAL

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

AFFINITY NT OXYGENATOR WITH BALANCE BIOSURFACE

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2024

WRENCH Kit 5873W

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLABA

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2024

AFFINITY NT Oxygenator with Balance Biosurface & Uncoated Cardiotomy/Venous Reservoir

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

ENT MR8™ Midas Rex Clearview™ Tools

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2024

MEDTRONIC ENT MR8™ High-Speed Drill System

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2024

TIPVISION Videoscope

Manufacturer:

SCHOLLY FIBEROPTIC, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 29, 2024

EleVision HD 2 CCU Image REC

Manufacturer:

SCHOLLY FIBEROPTIC GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 27, 2024

MEDTRONIC STEALTHSTATION S8

Manufacturer:

MEDTRONIC NAVIGATION, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2024

MEDTRONIC DBS Extension Kit for Deep Brain Stimulation

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 20, 2024

INTELLIS™ Neurostimulation for Chronic Pain

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 20, 2024

MEDTRONIC DIVERGENCE Reusable Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 5, 2024

MEDTRONIC Hancock II Mitral Obturators

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

ENVEO R Delivery Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

MELODY Transcatheter Pulmonary Valve

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 28, 2023

MEDTRONIC AVALUS Sizers

Manufacturer:

MEDTRONIC HEART VALVES DIVISON.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

MEDTRONIC CryoConsole System

Manufacturer:

MEDTRONIC CRYOCATH LP.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 19, 2023

Fortrex™ HP PTA Balloon Catheter

Manufacturer:

MEDTRONIC INC. (PLYMOUTH)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2023

VERTE STACK Spinal System Crescent

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.,HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2023

DIVERGENCE Anterior Cervical Fusion System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

ENVEO Pro Loading System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2023

CLEARVIEW Intracoronary Shunt

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

CARDIOBLATE Surgical Ablation Pen

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

MIDAS REX MR8 Drill System Attachments

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

FREEZOR Xtra Cardiac Cryoablation Catheters

Manufacturer:

MEDTRONIC CRYOCATH LP

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 6, 2023

MEDTRONIC Patient Programmer MRI SureScan

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 4, 2023

SYNCHROMED II Infusion Pump

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 4, 2023

MEDTRONIC Coaxial Umbilical Cable

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 4, 2023

MEDTRONIC Autotransfusion Blood Collection Reservoir EL2120

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

COVIDIEN Somanetics Invos Oximeter

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2023

MEDTRONIC Catheter Passer

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 28, 2023

MEDTRONIC OPEN PIVOT AP360 HEART VALVE AORTIC, Model 505DA

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 28, 2023

ASCENDA Intratechal Catheter 73 cm Pump Segment Revision Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 28, 2023

PROFILE 3D™ Sizer Set 7680S

Manufacturer:

MEDTRONIC HEART VALVES DIVISIONS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 27, 2023

KANGHUI Omnail Femoral Nail KGD II Instrument Set

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 24, 2023

ASCENDA Intrathecal Catheter with an 66 cm Spinal Segment

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 24, 2023

LOSS

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2023

VECTRIS SURESCAN MRI ( Subcompact Lead Kit for Spinal Cord Stimulation)

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 18, 2023

MEDTRONIC Special Holding Bag 1000ml

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

COVIDIEN NELLCOR SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2023

VALLEYLAB ™ Micro-Needle Electrodes

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

HANCOCK II T505

Manufacturer:

MEDTRONIC HEART VALVES

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

INDERMIL® flexifuze™ Topical Tissue Adhesive

Manufacturer:

CONNEXICON MEDICAL LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

SPECIFY SURESCAN MRI Lead Kits

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 14, 2023

VALLEYLAB™ Electrodes

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

SHILEY™ Endobronchial Tube/Left

Manufacturer:

MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

VC2 Veneous Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

BECKER External Drainage and Monitoring System

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

DLP Y-Adapter

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

MEDTRONIC Suction and Anticoagulation Assembly

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

MEDTRONIC Autotransfusion Blood Collection Reservoir

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

DUET External Drainage and And Monitoring System (EDMS)

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

MEDTRONIC Cardiotomy Reservoir

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

FREEZOR Cardiac Cryoablation Catheters

Manufacturer:

MEDTRONIC CRYOCATH LP

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

FREEZOR MAX Cardiac Cryoablation Catheters

Manufacturer:

MEDTRONIC CRYOCATH LP

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

MC2 Two Stage Veneous Cannula

Manufacturer:

VIANT MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

ARCTIC FRONT ADVANCE PRO

Manufacturer:

MEDTRONIC CRYOCATH LP

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

AUTOLOG Wash Kit

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2023

EOPA CAP Arterial Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2023

DLP Single Stage Veneous Cannula with Right Angled Tip

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

DLP Multiple Perfusion Set

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

ARCTIC FRONT ADVANCE Cardiac CryoAblation Catheter

Manufacturer:

MEDTRONIC CRYOCATH LP.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 18, 2023

MEDTRONIC Waste Bag, Universal 10 Liter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2023

Cardiotomy Reservoir EL400

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2023

MEDTRONIC Catheter Connecting Cable

Manufacturer:

CEA GLOBAL DOMINICANA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2023

TRUCLEAR ™ Hysteroscope Set Duo

Manufacturer:

HENKE-SASS WOLF, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

MEDTRONIC Open Pivot Heart Valve Sizer Set-576

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

DLP Pericardial Sump

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

DLP Coronary Ostial Perfusion Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2023

INVOS™ PM7100 Patient Monitor

Manufacturer:

ADVANTECH CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

HELI-FX ENDOANCHOR Systems

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 4, 2023

SYMPLICITY SPYRAL Multi-electrode Renal Denervation Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 30, 2023

SPRINTER LEGEND Rapid Exchange Balloon Dilatation Catheter

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2023

TruClear Tissue Removal Shaver

Manufacturer:

VIANT AS&O HOLDINGS, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

RESOLUTE ONYX Zotarolimus-Eluting Coronary Stent System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 21, 2023

RESOLUTE INTEGRITY Zotarolimus-Eluting Coronary Stent System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 21, 2023

NC EUPHORA Rapid Exchange Balloon Dilatation Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

SURGITIE™ AUTO SUTURE™ Ligating Loop with Delivery System

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

EUPHORA Rapid Exchange Balloon Dilatation Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2023

THUNDER Guidewires

Manufacturer:

CEA GLOBAL DOMINICANA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2023

INTUITION Steerable Guidewire Hydro-Track

Manufacturer:

CEA GLOBAL DOMINICANA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2023

INTUITION Steerable Guidewire Pro/Pel

Manufacturer:

CEA GLOBAL DOMINICANA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2023

ONYX TruStar Zotarolimus-Eluting Coronary Stent System

Manufacturer:

METRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

RADIANT Balloon Expandable Covered Stent

Manufacturer:

ATRIUM MEDICAL CORPORATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

Midas Rex MR8 Drill System Surgical Dissecting Tools

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2023

SENTRANT Introducer Sheath with Hydrophilic Coating

Manufacturer:

TELEFLEX MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

MIDAS REX Drill System Handpieces

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

TALENT Endoluminal Occluder System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 28, 2023

MIDAS Rex Curved Bur

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

ENDURANT IIs Stent Graft System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2023

MEDTRONIC Aortic Punch

Manufacturer:

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

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2023

MIDAS REX MR8 Drill System Handpieces

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2023

RELIANT Stent Graft Balloon Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2023

MIDAS REX MR8 Clearview Surgical Dissecting Tools

Manufacturer:

MEDTRONIC XOMED INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

Cutter Driver for the HawkOne™ Directional Atherectomy System

Manufacturer:

ATL TECHNOLOGY DG LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2023

MEDTRONIC HawkOne™ Directional Atherectomy System

Manufacturer:

MEDTRONIC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2023

MEROCEL

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 11, 2023

ADMIRAL XTREME PTA Balloon Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

NIM TRIVANTAGE EMG Endotracheal Tube

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2023

NIM FLEX EMG Endotracheal Tube

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

KANGHUI General Spine System (CoCr Rod)

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2023

VISI-PRO Balloon-Expandable Peripheral Stent System

Manufacturer:

EV3, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 1, 2023

ENDO-SCRUB® 2 SHEATH

Manufacturer:

MEDTRONIC XOMED INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2023

COVIDIEN Parietene DS Composite Mesh

Manufacturer:

SOFRADIM PRODUCTION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2023

MEDTRONIC WIRELESS EXTERNAL NEUROSTIMULATOR

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 12, 2023

CALIMA BLOWER 220-240V

Manufacturer:

VINCENT MEDICAL (DONGGUAN) TECHNOLOGY CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2023

RESOLUTE ONYX Zotralimus-Eluting Coronary Stent System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 4, 2023

PROGRIP Self-Gripping Polyester Mesh

Manufacturer:

SOFRADIM PRODUCTION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 25, 2023

MEDTRONIC Controller

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2023

MEDTRONIC UNIVERSAL II Slitter 6230UNI

Manufacturer:

MEDTRONIC INC, MOUNDS VIEW.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 19, 2023

AZURE XT DR MRI SureScan

Manufacturer:

MEDTRONIC SINGAPORE OPERATIONS PTE.LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 8, 2023

SENSIGHT Directional Lead Kit B33005

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 7, 2023

Select 3D II Arterial Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2023

PROGRIP Self-Gripping Polypropylene Mesh

Manufacturer:

SOFRADIM PRODUCTION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2023

SHILEY™ Pediatric Tracheostomy Tube Cuffless

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2023

LIGASURE Maryland Jaw Laparoscopic Sealer/Dividers

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

LIGASURE Blunt Tip Sealer/Divider, Nano-coated

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2023

HAZE

Manufacturer:

CELSIUS MEDICAL, S.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

PARIETENE Flat Sheet Mesh and Lightweight Mesh

Manufacturer:

SOFRADIM PRODUCTION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2023

ECO Posterior Thoracolumbar Fixation System

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

KANGHUI ECO MIS Minimally Invasive Posterior Thoracolumbar Implant

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

SHILEY Nasopharyngeal Airway

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2023

PARIETEX™ Hydrophilic Mesh

Manufacturer:

SOFRADIM PRODUCTION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

MYCARELINK Patient Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

ARCTIC FRONT ADVANCE PRO

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 3, 2023

MYCARELINK Patient Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

CARELINK SMARTSYNC Device Manager Base

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

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

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2023

MEDTRONIC Brockenbrough Curved Needle

Manufacturer:

MEDTRONIC MEXICO S. DE R.L DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2023

BIO-MEDICUS™ Adult Venous Cannula Kits

Manufacturer:

MEDTRONIC MEXICO S.DE R.L.DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2023

StraighShot Handpiece Accessories

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

MEDTRONIC ENT Burs

Manufacturer:

COVIDIEN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 2, 2023

SLIDE-ON ENDOSHEATH SYSTEM

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ENT CHANNELED SHEATH SLIDE-ON ENDOSHEATH System

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2023

TNE-D ENDOSHEATH SYSTEM FOR THE TNE-2000D ESOPHAGOSCOPE

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2023

Shiley ™ Oral/Nasal Endotracheal Tube Intermediate Cuff Non DEHP

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

SKEETER Oto-Flex Burs

Manufacturer:

COVIDIEN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

MEDTRONIC Scholarship

Manufacturer:

COVIDIEN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

COVIDIEN Sinus Secretion Collector

Manufacturer:

COVIDIEN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

TIMESH System

Manufacturer:

MEDTRONIC NEUROSURGERY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

COVIDIEN 4K/UHD Laparoscope

Manufacturer:

HENKE-SASS, WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

PATIENT PROGRAMMER TH90D

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 29, 2022

SENSIGHT™ Depth Stop and Cranial Tunneler Kit

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2022

SENSIGHT™ Extension Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 21, 2022

COVIDIEN 4K/UHD Arthroscope

Manufacturer:

HENKE-SASS, WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

MEDTRONIC EVOLUT Pro Plus System

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 12, 2022

KANGHUI CORMATE Implant

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

INSPIRED Ventilation Breathing Circuit

Manufacturer:

VINCENT MEDICAL (DONG GUANG) MANUFACTURING CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

EVOLUT™ PRO + Delivery Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 30, 2022

TIMESH System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2022

HYSTEROLUX Fluid Management System

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2022

EVOLUT Pro + Loading System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

KANGHUI Eco Deformity Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 14, 2022

SENSIGHT Extension Tunneler Kit

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

SENSIGHT Burr Hole Device

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2022

AMPHIRION™ Deep PTA Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2022

EXPORT™ AP

Manufacturer:

MEDTRONIC VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2022

KANGHUI CAPMATE Implant

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2022

MEDTRONIC Carelink Programmer

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 20, 2022

SONICISION™ 7 Curved Jaw Cordless Ultrasonic Dissection

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2022

KANGHUI CAPMATE Peek Cage Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2022

Stealth Autoguide System

Manufacturer:

MEDTRONIC NAVIGATION, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2022

BIO-PROBE Disposable Insert DP38 Adult

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2022

EXPORT ADVANCE™ Aspiration Catheter

Manufacturer:

MEDTRONIC VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2022

KANGHUI Implant -Trauma

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2022

VALLEYLAB™ Telescoping Smoke Evacuation Rocker Switch Pencil Edge™ Blade Electrode

Manufacturer:

NEW DEANTRONICS TAIWAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2022

ADMIRAL™ XTREME PTA Catheter

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2022

COVIDIEN PTFE Polymer Pledgets Nonabsorbable Pre-punched Pledgets

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2022

KANGHUI Titanium Implant interlocking Nail

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2022

SOLITAIRE AB Neurovascular Remodeling Device

Manufacturer:

MICRO THERAPEUTICS, INC, D/B/A EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 4, 2022

KANGHUI Trauma Screw Large

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2022

MCGRATH X BLADE X3 Disposable Laryngoscope Blade

Manufacturer:

MEDICONCEPTS TECHNOLOGY (SHENZHEN) COMPANY LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2022

PERCEPT PC BrainSense

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 22, 2022

MCGRATH MAC Disposable Laryngoscope Blade

Manufacturer:

VITALTEC CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 23, 2022

MINIMED™ Silhouette Infusion Set, SC1

Manufacturer:

UNOMEDICAL DEVICES SA. OF C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2022

MINIMED™ Mio Infusion Set, SC1

Manufacturer:

UNOMEDICAL DEVICES SA. OF C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2022

MINIMED™ Quick Set Infusion Set, SC1

Manufacturer:

UNOMEDICAL DEVICES SA. OF C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 14, 2022

BIO-MEDICUS Life Support Arterial Catheter (LS96010)

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 11, 2022

BL250 Kit 025 CVVH/CVVHD

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2022

MINIMED™ Sure T Infusion Set, SC1

Manufacturer:

UNOMEDICAL DEVICES SA. OF C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 5, 2022

CARPEDIEM BL250 Kit 0075 CVVH

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2022

PIPELINE Flex Embolization Device with Shield Technology

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 1, 2022

BL250 Kit 015 CVVH/CVVHD

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 28, 2022

FORTREX 0.035" OTW PTA Balloon Catheter

Manufacturer:

COVIDIEN LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 28, 2022

REBAR -27 Micro Catheter

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 26, 2022

RAPIDCROSS™ PTA Rapid Exchange Balloon Dilatation Catheter

Manufacturer:

EV3, Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 26, 2022

HYPERGLIDE Occlusion Balloon System

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

BIO-MEDICUS Life Support Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2022

CAPNOSTREAM 35 Portable Respiratory Monitor

Manufacturer:

SANMINA HUNTSVILLE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 23, 2022

MARKSMAN Catheter

Manufacturer:

MEDTRONIC MEXICO S, DE R.L DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 22, 2022

MEDTRONIC Single Chamber Temporary External Pacemaker 53401

Manufacturer:

PLEXUS MANUFACTURING SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 20, 2022

TruClear Operative Hysteroscopes

Manufacturer:

HENKE-SASS WOLF, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 19, 2022

W.O.M. Laparoscopy Pump (LAP-Pump) and Accessories

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

TRUCLEAR Elite Hysteroscopes

Manufacturer:

HENKE-SASS WOLF, GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

DLP Pediatric One Piece Arterial Cannulae

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 10, 2022

COVIDIEN Insufflator 50L and Accessories

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

TRUCLEAR Hysteroscopic Tissue Removal System

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2022

VENASEAL Closure System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 27, 2022

INVOS PM7100 Patient Monitor and Accessories

Manufacturer:

AVNET GLOBAL SOLUTION CENTER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 27, 2022

LIGASURE Retractable L-Hook Laparoscopic Sealer/Divider

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 27, 2022

MVP Micro Vascular Plug System

Manufacturer:

COVIDIEN

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 27, 2022

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

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2022

SONICISION Curved Jaw Cordless Ultrasonic Dissector

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2022

SIGNIA™ Loading Units with Tri-Staple™ 2.0 Cartridges

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

VALLEYLAB™ REM Adult Universal Patient Return Electrode

Manufacturer:

COVIDIEN DEUTSCHLAND GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider 12 mm - 12 cm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

ARGON Electrode

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 23, 2022

NELLCOR Portable SpO2 Patient Monitoring System

Manufacturer:

MEDIAN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 21, 2022

DAR Infant Breathing Circuit

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 21, 2022

SURGINEEDLE™ Auto Suture™ Insufflation Needle

Manufacturer:

CELESTICA DE MONTERREY S.A DE CV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2022

VALLEYLAB™ Smoke Evacuation Pencil

Manufacturer:

MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2022

LIGASURE Exact Dissector, Nano-coated, 20.6 mm - 21 cm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2022

SHILEY Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy Eye

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

SURGISLEEVE Wound Protector

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2022

TRI-STAPLE™ 2.0 and Reinforced 2.0 Reloads

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 13, 2022

ENDO GIA™ Curved Tip Reload with Tri-Staple™ Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 11, 2022

ENDO DISSECT AUTO SUTURE Dissector 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2022

COVIDIEN Otoskop (Otoscope)

Manufacturer:

HENKE-SASS, WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

COREVALVE™ EVOLUT™ R Transcatheter Aortic Valve

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 2, 2022

COREVALVE™ EVOLUT™ PRO Transcatheter Aortic Valve

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 2, 2022

INSPIRED™ Auto-feed Humidification Chamber

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2022

COVIDIEN Nasoskop (Sinuscope)

Manufacturer:

HENKE-SASS, WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2022

MICROSTREAM™ Advance Filter Lines

Manufacturer:

QUASAR MEDICAL (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 23, 2022

MICROSTREAM™ Advance Filter and Luer Sampling Lines

Manufacturer:

QUASAR MEDICAL (THAILAND) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2022

HISERN Disposable Anesthesia Mask

Manufacturer:

ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 16, 2022

AMPLATZ Goose Neck Snare and Kit

Manufacturer:

EV3 INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2022

COVIDIEN Zystoskop (Cystoscope)

Manufacturer:

HENKE-SASS, WOLF GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

HISERN Disposable Anesthesia Breathing Circuit

Manufacturer:

ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 9, 2022

PHENOM™ Catheters

Manufacturer:

MEDTRONIC MEXICO S DE R L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 9, 2022

AMPLATZ GOOSE NECK Microsnare and Kit

Manufacturer:

EV3 INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 7, 2022

INSPIRED Ventilator Humidifier

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2022

PURITAN BENNETT 980 Universal Ventilator

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2022

PURITAN BENNETT 980 Universal Ventilator Pendant Configuration Ventilator

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2022

PURITAN BENNETT 980 Ventilator

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2022

VALLEYLAB™ REM POLYHESIVE™ Patient Return Electrode

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2022

CROME™ VR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 24, 2022

CROME™ VR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 24, 2022

CROME™ DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 24, 2022

KANGHUI Titanium Implant Screw Spine

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 20, 2022

KANGHUI Titanium Implant Screw

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 20, 2022

CROME™ HF CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2022

CROME™ DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2022

CROME™ HF Quad CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2022

CROME™ HF CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 18, 2022

CROME™ HF Quad CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 14, 2022

KANGHUI Trauma Screw Small Mini

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 13, 2022

KANGHUI NEOGEN

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 10, 2022

INSPIRED Heated Breathing Circuit

Manufacturer:

VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2022

COBALT™ XT DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 8, 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™ HF CRT-D MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 8, 2022

KANGHUI ECO Implant

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 31, 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

INTELLIS™ AdaptiveStim

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 29, 2021

KANGHUI ECO Orthopedic Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 21, 2021

SHILEY™ Endobronchial Tube Left with Carinal Hook

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2021

BL250 Pre-assembled Device for Neonatal and Pediatric Hemofiltration/Hemodialysis

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2021

KANGHUI Bone Screws

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2021

VARILOC Bone Plates

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2021

ARCTIC FRONT ADVANCE™ Cardiac CryoAblation Catheter

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 7, 2021

Pipeline™ Vantage Embolization Device with Shield Technology™

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 2, 2021

CARPEDIEM

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2021

MEDTRONIC StealthStation FlexENT™

Manufacturer:

MEDTRONIC NAVIGATION, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2021

EPISTAT Nasal Catheter

Manufacturer:

COVIDIEN

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 5, 2021

TICRON™ Coated and Uncoated Braided Polyester

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2021

COVIDIEN Shiley™ Pediatric Tracheostomy Tube with TaperGuard™ Cuff

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2021

SELECTSECURE MRI SureScan

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 13, 2021

KANGHUI Topfix Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 25, 2021

MyCareLink Patient Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2021

ACTIVE RC

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO JUNCOS.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 16, 2021

SURGIPRO II Monofilament Polypropylene

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2021

KANGHUI Single-seater Tool

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 15, 2021

FLEXCATH ADVANCE™

Manufacturer:

MEDTRONIC CRYOCATH LP

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2021

CRESCENT Spinal System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2021

SELECTSITE™ C304-HIS Deflectable Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2021

STRATA II Adjusment Kit

Manufacturer:

PMC, LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2021

MEDTRONIC Restore Ultra SureScan

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2021

KABLP05 - KIT PEX X AMPLYA

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2021

KABL14P05 - KIT CPFA X AMPLYA

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2021

MAXON and MAXON CV Monofilament Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2021

Axium™ Prime Detachable Coil System

Manufacturer:

MEDTRONIC MEXICO S. DE R. L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 30, 2021

MEDTRONIC Epicardial Patch

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2021

MEDTRONIC Percutaneous Lead Introducer

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2021

MICROSTREAM Advance Filter and Luer Sampling Lines

Manufacturer:

QUASAR ELECTRONICS TECHNOLOGY (DONGGUAN) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2021

FLEXON Multifilament Temporary Cardiac Pacing Lead

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 24, 2021

LAUNCHER Guiding Catheter

Manufacturer:

MEDTRONIC MEXICO S.DE R. L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 15, 2021

SOFSILK Wax Coated and SOFSILK Silicon Coated Braided Silk

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 15, 2021

CONCERTO™ Detachable Coil System (PGLA)

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 9, 2021

BELLCO Drainage Bag

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2021

HANCOCK II Aortic Obturators

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 4, 2021

AXIUM™ Detachable Coil System (PGLA)

Manufacturer:

MEDTRONIC MEXICO S. DE R. L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

AZURE™ XT DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

VIVA CRT - P

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2021

NEO SUPRA Intramedullary Nails

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2021

MEDTRONIC External Drainage and Monitoring Catheters

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2021

GIA Stapler with Tri-Staple Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2021

MIDAS REX MR8 Clearview Surgical Dissecting Tools

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 15, 2021

INNERVISION

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 15, 2021

MEDTRONIC External Drainage and Monitoring Catheter

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 15, 2021

AXIUM™ Detachable Coil System

Manufacturer:

MEDTRONIC MEXICO S. DE R. L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 11, 2021

AXIUM™ Detachable Coil System (Nylon)

Manufacturer:

MEDTRONIC MEXICO S. DE R. L. DE CV

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 11, 2021

MEDTRONIC Electrode

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

CONTEGRA 200 Pulmonary Valved Conduit (Unsupported)

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 20, 2021

BL640 KIT HFR 17 (HFR Evolution Therapy)

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

CRAGG-MCNAMARA™ 5F Valved Infusion Catheter

Manufacturer:

COVIDIEN FORMERLY MALLINCRODT MEDICAL CORMANADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

Valleylab™ Laparoscopic Smoke Evacuation System Active, Passive

Manufacturer:

CONSOLIDATED MEDICAL EQUIPMENT COMPANY (CONMED)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

KANGHUI Instrument

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2021

KANGHUI Instrument Trauma

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2021

KANGHUI Titanium Implant Plate Spine

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

EMPRINT™ Ablation Generator with THERMOSPHERE™ Technology

Manufacturer:

EMBLATION LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 1, 2021

CLEARIFY™ Visualization System

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

VALLEYLAB™ Smoke Attachment

Manufacturer:

NEW DEANTRONICS TAIWAN LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

CRAGG-MCNAMARA™ 4F Valved Infusion Catheter

Manufacturer:

COVIDIEN FORMERLY MALLINCRODT MEDICAL CORMANADDY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 1, 2021

PREVAIL™ Paclitaxel-coated PTCA Balloon Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 22, 2021

TRI-AD 2.0 Adam Band Sizer Set

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 21, 2021

BL640 KIT SUPRA 17

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2021

BL640 KIT SUPRA 13

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2021

BL640 KIT HFR AEQ – HFR17

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2021

ATTAIN Venogram Balloon Catheter

Manufacturer:

B.BRAUN MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2021

CARELINK ENCORE Programmer

Manufacturer:

PLEXUS MANUFACTURING SDN., BHD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 19, 2021

SAFESHEATH II Introducer System

Manufacturer:

OSCOR INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2021

CONFIDA Brecker Guidewire

Manufacturer:

EPFLEX FEINWERKTECHNIK GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 13, 2021

VALLEYLAB™ Disposable Electrosurgical Pencils

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 9, 2021

MEDTRONIC Trialing and Intraoperative Screening Cable

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 9, 2021

COVIDIEN NELLCOR Forehead SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

CONCERTO™ Detachable Coil System – PGLA Fiber

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2021

ABL14P05 - Pre-assembled device for CPFA for Amplya

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 6, 2021

ABLP05 - Pre-assembled device for PEX for Amplya

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 6, 2021

MEDTRONIC NERVE Monitoring System

Manufacturer:

MEDTRONIC XOMED INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2021

HBIOFLUIDS Haemofiltration and Dialysis Solution

Manufacturer:

HAEMOPHARM BIOFLUIDS S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2021

HBIOFLUIDS Sodium Citrate Solution

Manufacturer:

HAEMOPHARM BIOFLUIDS S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2021

BELLCO Pre-assembled device for RRT for Amplya

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2021

LIGASURE Dolphin Tip

Manufacturer:

COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2021

ABLE - Pre-assembled device for HP for Amplya

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2021

TICRON Coated and Uncoated Braided Polyester

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 25, 2021

AXIUM Detachable Coil System

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 25, 2021

SHILEY Hi-Lo Hand Pressure Gauge

Manufacturer:

VBM MEDIZINTECHNIK GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2021

DERMALON Monofilament Nylon

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 23, 2021

LIGASURE ATLAS™ Tissue Fusion

Manufacturer:

COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 23, 2021

Midas Rex Legend Depth Stop Attachments

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2021

VENASEAL Closure System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 20, 2021

ONYX Liquid Embolic System

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 20, 2021

AXIUM™ Prime Detachable Coil System

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 20, 2021

MEDTRONIC NIM TRIVANTAGE™ EMG Endotracheal Tube

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2021

KANGHUI Titanium Implant Plate

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 19, 2021

LIGASURE Curved, Small Jaw, Open Sealer/Divider 16.5 mm - 19 cm

Manufacturer:

COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 17, 2021

COVIDIEN NELLCOR Pediatric SpO2 Sensor Clip

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

SHILEY Endobronchial Tube / Left

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

WEM Bipolar Forceps

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 17, 2021

COVIDIEN NELLCOR Pediatric SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

SHILEY™ Oral/Nasal Tracheal Tube Cuffless, Murphy Eye

Manufacturer:

KENDALL-GAMMATRON CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 17, 2021

MONOSOF Monofilament Nylon

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2021

COVIDIEN Neonatal SpO2 Sensor

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

GIA Auto Suture Stapler with DST Series Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2021

SURGIPRO II Monofilament Polypropylene

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 9, 2021

SHILEY™ Oral RAE Tracheal Tube Cuffless / Murphy Eye

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

COOL-TIP RF Ablation Cluster Electrode Kit E Series

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

COOL-TIP RF Ablation System E Series

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

CRAGG-MCNAMARA™ 4F Valved Infusion Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

CRAGG-MCNAMARA™ 5F Valved Infusion Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

SHILEY Speaking Valve

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

LIGASURE™ Curved Jaw, Open Sealer/Divider

Manufacturer:

COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

COOL-TIP RF Ablation High Power Patient Return Electrode E Series

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2021

SHILEY Esophageal Tracheal Airway with X-Ray Line

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2021

SHILEY Tracheostomy Tube Cuffless with Inner Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2021

SHILEY Neonatal Tracheostomy Tube Cuffless

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2021

MONOSOF Monofilament Nylon

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

CELLO Balloon Guide Catheter, Intravascular Catheter with Cuff

Manufacturer:

FUJI SYSTEMS CORPORATION SHIRAKAWA PLANT

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

ECHELON™ -10 Micro Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

COVIDIEN PTFE Polymer Pledgets Nonabsorbable Pre-punched Pledgets

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

COVIDIEN Chromic Gut Absorbable Suture

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

PIPELINE Flex Embolization Device

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 3, 2021

VASCUFIL Coated Monofilament Polybutester

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2021

AXIUM Prime Detachable Coil System

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 3, 2021

WEM Monopolar Forceps

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

COOL-TIP RF Ablation Remote Temperature Probe E Series

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

NAVIEN Intracranial Support Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

COVIDIEN Insufflator

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

WEM Electrosurgical Electrode

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

CLEANCOAT™ Laparoscopic Curved Spatula Electrode Coated

Manufacturer:

NEW DEANTRONICS TAIWAN, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

FLEXON Multifilament Temporary Cardiac Pacing Lead

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 25, 2021

COVIDIEN Insufflator

Manufacturer:

W.O.M. WORLD OF MEDICINE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

SHILEY™ Oral/Nasal Tracheal Tube Cuffless / Reinforced

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

COOL-TIP RF Ablation Multiple Electrode Kit E Series

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2021

SIGNIA Forklift

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 18, 2021

REBAR -18 Micro Catheter

Manufacturer:

MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 16, 2021

ECHELON™ -14 Micro Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 16, 2021

COVIDIEN Electrosurgery Reusable Hand Instruments and Accessories

Manufacturer:

ACKERMANN INSTRUMENTE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2021

COVIDIEN Reusable Obturator

Manufacturer:

ACKERMANN INSTRUMENTE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2021

MARATHON Flow Directed Micro Catheter

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 11, 2021

SURGIPRO™ II Monofilament Polypropylene

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2021

AVIGO Hydrophilic Guidewire

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2021

ARGYLE™ Safety Fistula Cannula with Anti-Reflux Valve

Manufacturer:

NIPPON COVIDIEN LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

COOL-TIP RF Ablation Single Electrode Kit E Series

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

CLOSURERFG Radiofrequency Generator

Manufacturer:

PLEXUS CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

WEM Multifunctional Electrosurgical Handpiece

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 9, 2021

V-LOC™ PBT Non-absorbable Reload

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2021

VALLEYLAB™Laparoscopic Electrode, Solid

Manufacturer:

NEW DEANTRONICS TAIWAN, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2021

WEM Disposable Catheter for Electrosurgery

Manufacturer:

WEM ELECTRONIC EQUIPMENT LTDA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 8, 2021

COVIDIEN Suction Irrigation

Manufacturer:

ACKERMANN INSTRUMENTE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2021

ETH-Needle Holder

Manufacturer:

ACKERMANN INSTRUMENTE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2021

VALLEYLAB Fine Needle Electrode

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 3, 2021

VALLEYLAB™ Micro-Needle Electrode

Manufacturer:

VENUSA DE MEXICO S.A. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 3, 2021

CLOSURERFS Endovenous Radiofrequency Stylet

Manufacturer:

PRECISION CONCEPTS COSTA RICA S.A. (A.K.A PCMT)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 3, 2021

COVIDIEN Electrosurgery Instruments and Accessories

Manufacturer:

ACKERMANN INSTRUMENTE GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2021

VALLEYLAB™ Ball Electrodes

Manufacturer:

BOVIE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2021

ENDO MINI-SHEARS™ Auto Suture™ Shears

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2021

TA™ Auto Suture™ Loading Unit with DST Series™ Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 29, 2021

EDGE Electrosurgical Pencils

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 28, 2021

SURGIWAND™ II AUTO SUTURE™ Suction and Irrigation Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 28, 2021

ENDO DISSECT™ AUTO SUTURE™ Dissector with Roticulator™ Technology 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2021

SILS™ Port Flexible Port

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2021

ENDO CLIP™ Autosuture Clip Applier

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2021

PARAMOUNT Mini GPS Balloon – Expandable Biliary Stent System

Manufacturer:

EV3, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2021

ENDO DISSECT™ Auto Suture™ Dissector 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2021

DAR Adult Breathing Circuit

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2021

MEDTRONIC SOLO-TRAK-KR Percutaneous Lead Introducer (PLI)

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

COVIDIEN Adult SomaSensor®

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2021

COVIDIEN Trocar With Silicon Valve, Dismountable

Manufacturer:

ACKERMANN INSTRUMENTE GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 1, 2021

KENDALL Sterile Water for Inhalation USP with O2 Humidifier Adapter, 325 ml

Manufacturer:

COVIDIEN DEUTSCHLAND MANUFACTURING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 1, 2021

ENLITE Glucose Sensor

Manufacturer:

MEDTRONIC MINIMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 1, 2021

DAR Catheter Mount

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 1, 2021

ENDO CLOSE™ AUTO SUTURE™ Trocar Site Closure Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 1, 2021

MEDTRONIC Paradigm Insulin Pump

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2020

VALLEYLAB™ Tungsten Loop Electrodes

Manufacturer:

BOVIE MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2020

V-LOC 180 Absorbable Wound Closure Device

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2020

EVERCROSS™ .035" OTW PTA Dilatation Catheter

Manufacturer:

EV3 INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2020

VERSAONE™ Bladeless Swap

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2020

SHILEY Endobronchial Tube / Right

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2020

LIGASURE IMPACT™ Curved, Large Jaw, Open Sealer/Divider 36 mm - 18 cm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 22, 2020

ENDO CLIP™ AUTO SUTURE™ Clip Apply

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2020

SHILEY Adult Flexible Tracheostomy Tube with Taperguard Cuff, Reusable Inner Cannula

Manufacturer:

COVIDIEN FORMERLY MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2020

SHILEY™ Endobronchial Tube / Left with Carinal Hook

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2020

VERSAONE™ Bladed Trocar

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

McGRATH MAC Video Laryngoscope

Manufacturer:

AIRCRAFT MEDICAL LIMITED.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 18, 2020

COVIDIEN WarmTouch Blankets

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

FORCE TRIAD Energy Platform and Accessories

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2020

PALINDROME Precision HSI Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2020

LIGASURE™ Maryland Jaw Sealer/Divider

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

AMPLYA

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

PALINDROME SI Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

PALINDROME H Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

PALINDROME HSI Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2020

MAHURKAR Elite Acute Triple Lumen Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2020

PALINDROME Precision H Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2020

MEDTRONIC Paradigm Insulin Pump-MMT-515

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

PALINDROME Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2020

SHILEY™ Oral/Nasal Tracheal Tube Cuffed / Reinforced with Stylet

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

SELECTSECURE MRI SureScan

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 7, 2020

KANGHUI Instrument Spine

Manufacturer:

CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 7, 2020

MEDTRONIC Paradigm Insulin Pump-MMT-715

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

DAR Adult-Pediatric Electrostatic Filter HME

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

SHILEY™ Tracheostomy Tube Cuffless with Inner Cannula

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2020

BIO-MEDICUS Venous Insertion Kit

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2020

SHILEY TaperGuard Evac Oral Tracheal Tube

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2020

CONTOUR 3D Sizer Set 7690S

Manufacturer:

MEDTRONIC HEART VALVES DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 3, 2020

DAR Pediatric-Neonatal Closed Suction System

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2020

PALINDROME Precision SI Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2020

MEDTRONIC VALVE HANDLE

Manufacturer:

MEDTRONIC HEART VALVES DIVISON.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2020

MEDTRONIC Valve Handle

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 2, 2020

INTRASTENT™ LD MEGA™ Large Diameter Peripheral Stent

Manufacturer:

EV3, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2020

PARADIGM Insulin Pump-MMT 522

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

ENDO CLINCH™ II AUTO SUTURE™ Grasper 5mm

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

TRI-AD 2.0 Adams Tricuspid Band

Manufacturer:

MEDTRONIC MEXICO S DE R.L DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2020

AZURE XT SR MRI SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 29, 2020

MAHURKAR Elite Acute Dual Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2020

SHILEY™ Oral RAE Tracheal Tube Cuffed / Murphy Eye

Manufacturer:

MALLINCKRODT MEDICAL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

AZURE™ S SR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 26, 2020

SHILEY™ Hi-Contour Oral/Nasal Tracheal Tube Cuffed Murphy Eye

Manufacturer:

COVIDIEN LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

MEROCEL Nasal Dressing

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2020

SURE-T Paradigm

Manufacturer:

UNOMEDICAL DEVICES S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2020

MEDTRONIC Indigo HighSpeed Otologic Drill

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2020

DAR Closed Suction System

Manufacturer:

MALLINCKRODT DAR S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2020

MEDTRONIC Annuloplasty Handle

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2020

MEDTRONIC Annuloplasty Handle

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2020

SONICISION Battery Powered Devices

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2020

PRIMEADVANCED Surescan MRI

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 19, 2020

MEDTRONIC MINIMED Quick Serter

Manufacturer:

SMC COSTA RICA DIVISION S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2020

MIDAS REX® Legend® Surgical Dissecting Tools

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2020

AZURE™ S DR MRI SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 15, 2020

MEDTRONIC External Neustimulator

Manufacturer:

MEDTRONIC NEUROMODULATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2020

BIO-MEDICUS Arterial Insertion Kit

Manufacturer:

MEDTRONIC MEXICO S.DE R.L.DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 10, 2020

LR-ACT

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2020

CAPSTONE PTC™ Spinal System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 4, 2020

CLARIA MRI™ CRT-D SureScan™

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 4, 2020

AMPLIA MRI Quad CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 4, 2020

Amplia MRI CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 2, 2020

TA™ Auto Suture Stapler with DST Series™ Technology

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2020

TORQR

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2020

LIGASURE Blunt Tip Sealer/Divider

Manufacturer:

COVIDIEN

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2020

BELLCO Blood and Infusion lines for extracorporeal circulation

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2020

AMPLIA MRI CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 22, 2020

Wide MRI Quad CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 19, 2020

FORCLEAN POLYPHE i

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 16, 2020

INTERSTIM ICON Patient Programmer

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2020

ACTIVE SC

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 16, 2020

FORCE FX™ Electrosurgical Generator 8CS 240 V

Manufacturer:

COVIDIEN Medical Products (Shanghai) Manufacturing LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 16, 2020

N'VISION Clinician Programmer

Manufacturer:

MEDTRONIC NEUROMODULATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2020

SONICISION Cordless Ultrasonic Dissection

Manufacturer:

COVIDIEN.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 12, 2020

ACT Easy Fill Device

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 12, 2020

FORCLEAN POLYPHE PLUS

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 12, 2020

RAPIDVAC Smoke Evacuator

Manufacturer:

BUFFALO FILTER LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2020

VALLEYLAB LS Series Single Channel Vessel Sealing

Manufacturer:

COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING LLC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2020

CLARIA MRI Quad CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 7, 2020

STREAMLINE Unipolar Pediatric Temporary Pacing Lead

Manufacturer:

MEDTRONIC FABRICATION S.A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2020

MEDTRONIC Bio Console 560

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2020

MEDTRONIC Spinal Needle

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2020

Claria MRI CRT-D SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 2, 2020

CARDIOBLATE BP2 Ablation Device

Manufacturer:

CEA MEDICAL MANUFACTURING, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2020

MEDTRONIC Angiographic Guide Wire

Manufacturer:

MEDTRONIC VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2020

FORCLEAN THERAPY i

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2020

MEDTRONIC Percutaneous Lead Introducer

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

SUPRA 17

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2020

ENVEO R Loading System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2020

SAFE SHEATH (HLS series)

Manufacturer:

MERIT MEDICAL SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2020

MEDTRONIC HR-HTC

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

ASCENDA INTRATHECAL CATHETER 8780 SPINAL SEGMENT

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 6, 2020

MEDTRONIC Personal Therapy Manager

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 6, 2020

MEDTRONIC RACT

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2020

MEDTRONIC HR-ACT Temperature Catridges

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2020

FORMULA Plus

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2020

EVERA MRI S DR SureScan

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2020

HFR17 (HFR Aequilibrium Therapy)

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2020

MEDTRONIC MyCareLink Patient Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 24, 2020

SUPRA 13

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2020

OLpur MD Filter

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2020

FORMULA 2000 Plus

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2020

INTERSTIM Quadripolar Lead for Electrical Stimulation

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 16, 2020

HEARTWARE WHAT CONTROLLER

Manufacturer:

HEARTWARE, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 11, 2020

FORCLEAN Therapy Plus

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2020

BL352 Infusion Line Formula Therapy MID/HDF

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2020

BELLCO Hollow fiber dialyzer BLS Series 500

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2020

REVEAL XT

Manufacturer:

MEDTRONIC EUROPE SARL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2020

FORMULA Plus

Manufacturer:

BELLCO S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2020

FORMULA Therapy

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2020

FORMULA 2000 Plus

Manufacturer:

BELLCO S.R.L.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2020

BELLCO Hollow fiber dialyzer BLS Series 800

Manufacturer:

BELLCO S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2020

SOLUCART Plus

Manufacturer:

LABARATOIRE SOLUDIA S.A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2020

MEDTRONIC MyCareLink Patient Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN. BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2020

MEDTRONIC MyCareLink Patient Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2020

CRYSTALLINE ACTFIX Lead

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 23, 2020

SPRINTER LEGEND OTW Balloon Dilatation Catheter

Manufacturer:

MEDTRONIC MEXICO S. DE R. L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2020

VALIANT NAVION™ Thoracic Stent Graft System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 17, 2020

VISIA AF MRI XT VR SURESCAN

Manufacturer:

MEDTRONIC EUROPE S.A.R.L.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 12, 2020

EVEREST 20 Survival Kit

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2020

MEDTRONIC Epicardial Patch

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2020

MEDTRONIC Tunneling Tool

Manufacturer:

MEDTRONIC, INC. Mounds View

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 24, 2020

MEDTRONIC Reusable Instrument

Manufacturer:

MEDTRONIC SOFAMOR DANEK USA INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 23, 2020

PACIFIC Plus PTA Catheter

Manufacturer:

INVATEC S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2020

PACIFIC XTREME PTA Balloon Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2020

SELECTSITE Deflectable Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2020

QUICK-SET Infusion Set

Manufacturer:

UNOMEDICAL DEVICES SA. OF C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2020

MEDTRONIC Reservoir Paradigm Infusion Pump

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2020

MEDTRONIC NIM-ECLIPSE Controller

Manufacturer:

MEDTRONIC XOMED, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2020

DURAN ANCORE Sizer Set

Manufacturer:

MEDTRONIC HEART VALVES DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 19, 2020

MEDTRONIC Ventricular Catheters

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2020

MEDTRONIC MIDAS REX EHS System

Manufacturer:

MEDTRONIC POWERED SURGICAL SOLUTIONS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2020

BIO-MEDICUS One Piece Femoral Veneous Cannula

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 15, 2020

OPUS

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 15, 2020

MEDTRONIC Nerve Integrity Monitor (NIM) System

Manufacturer:

MEDTRONIC XOMED, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2020

MEDTRONIC DBS Patient Programmer

Manufacturer:

MEDTRONIC NEUROMODULATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2020

MEDTRONIC COREVALVE EVOLUT R System

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 8, 2020

ENLITE Serter- MMT 7510

Manufacturer:

MEDTRONIC MINIMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 6, 2020

DLP Tourniquet Kit

Manufacturer:

VIANT MEDICAL INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 1, 2020

PASSERS

Manufacturer:

MEDTRONIC DOMINICANA (MANUFACTURA) S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2020

GUARDIAN REAL-Time Continuous Glucose Monitoring System

Manufacturer:

MEDTRONIC MINIMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2020

iPro 2 Professional CGM System

Manufacturer:

MEDTRONIC MINIMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 17, 2020

QUICK-SET PARADIGM Infusion Set

Manufacturer:

UNOMEDICAL DEVICES SA. FROM. RESUME.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 17, 2020

iPort Advance ™ Injection Port

Manufacturer:

UNOMEDICAL DEVICES S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 15, 2020

MIO Infusion Set

Manufacturer:

UNOMEDICAL DEVICES S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 15, 2020

MEDTRONIC XOMED Ventilation Tubes

Manufacturer:

MEDTRONIC XOMED INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 14, 2020

FlexiLux 200 LED, LED light source with Multi light guide adapter

Manufacturer:

SCHOLLY FIBEROPTIC, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2020

ENDEAVOR RESOLUTE Zotarolimus-Eluting Coronary Stent System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 27, 2020

DELTA Shunt Kit

Manufacturer:

MEDTRONIC NEUROSURGERY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 19, 2020

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:

Mar 9, 2020

MAHURKAR Acute Dual Lumen Catheters and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 9, 2020

AFFINITY Pediatric Arterial Filter

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2020

MEDTRONIC Sil Serter

Manufacturer:

SMC COSTA RICA DIVISION S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2020

AFFINITY Fusion Oxygenator

Manufacturer:

MEDTRONIC PERFUSION SYSTEMS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2020

MEDTRONIC Quick Serter

Manufacturer:

SMC COSTA RICA DIVISION S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2020

MEDTRONIC CareLink Express Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2020

MEDTRONIC CareLink Express Monitor

Manufacturer:

PLEXUS MANUFACTURING SDN., BHD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2020

MEDTRONIC Restore Sensor SureScan

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS, JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 28, 2020

SHILEY Laryngeal Mask

Manufacturer:

FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 21, 2020

MEDTRONIC External Drainage and Monitoring Ventricular Catheter

Manufacturer:

MEDTRONIC NEUROSURGERY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 12, 2019

MULLINS Transseptal Catheter Introducer

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2019

INPUT TS Introducer Sheath

Manufacturer:

AVAILMED S.A. DE C.V. (MEXICO)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2019

REVEAL LINQ Insertion Tools

Manufacturer:

MEDTRONIC INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 27, 2019

NC SPRINTER Rapid Exchange Balloon Dilatation Catheter

Manufacturer:

MEDTRONIC MEXICO S. DE R.L. DE CV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2019

MEDTRONIC CSF-Unitized Shunts

Manufacturer:

MEDTRONIC NEUROSURGERY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2019

PROVIA Steerable Guidewire

Manufacturer:

CEA GLOBAL DOMINICANA S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2019

SOLITAIRE™ Platinum Revascularization Device

Manufacturer:

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2019

EXPORT AP Aspiration Catheter

Manufacturer:

MEDTRONIC VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2019

SILHOUETTE PARADIGM

Manufacturer:

UNOMEDICAL DEVICES S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 29, 2019

SILHOUETTE PARADIGM Short

Manufacturer:

UNOMEDICAL DEVICES S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 28, 2019

MEDTRONIC Divergence Instrument- Sterile

Manufacturer:

MEDTRONIC SOFAMOR DANEK MANUFACTURING.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 28, 2019

MEDTRONIC Capsure SP Novus

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 23, 2019

AMPHIRION DEEP PTA Balloon Catheter

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 6, 2019

INTEGRITY Rapid Exchange Coronary Stent System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 30, 2019

DIVERGENCE™ Anterior Cervical Fusion System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2019

PALINDROME Precision Chronic Catheter and Kits

Manufacturer:

COVIDIEN MANUFACTURING SOLUTIONS SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2019

MEDTRONIC EVOLUT PRO SYSTEM

Manufacturer:

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

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 19, 2019

MEDTRONIC Restore Advance SureScan

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS, JUNCOS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2019

EnVeo Pro Delivery Catheter System

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 13, 2019

MEDTRONIC Subcutaneous Lead System

Manufacturer:

MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 1, 2019

Camera Head Full HD Zoom

Manufacturer:

SCHOLLY FIBEROPTIC GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2019

IN. PACT PACIFIC Paclitaxel-Eluting PTA Balloon Catheter

Manufacturer:

MEDTRONIC IRELAND

Class:

Kelas : 1

Risk Class:
Kelas Resiko : D
Registration Date:

May 31, 2019

Flexilux II Laparoscope

Manufacturer:

SCHOLLY FIBEROPTIC, GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2019

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

Last updated: December 2025