Pure Global
Authorized representative profile

PT. MEDTRONIC INDONESIA

Indonesia flagIndonesia·786 products represented·212 manufacturers
Registered address
Address
Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama
786
Total Products
212
Manufacturers
3
Product Classes
4
Risk Classes
Risk classification breakdown

Distribution of represented products across risk classes

Kelas Resiko : A
65
8.3% of total
Kelas Resiko : B
200
25.4% of total
Kelas Resiko : C
366
46.6% of total
Kelas Resiko : D
155
19.7% of total
Manufacturer portfolio

Products organized by manufacturer

COVIDIEN
United States
126 Products
V-LOC™ PBT Non-Absorbable Wound Closure DeviceFeb 7, 2025
Kelas Resiko : C
APPOSE ULC Auto Suture Slim Body Skin StaplerFeb 5, 2025
Kelas Resiko : C
ENDO GIA Ultra Universal StaplerFeb 5, 2025
Kelas Resiko : C
COVIDIEN Plain Gut Absorbable SutureFeb 5, 2025
Kelas Resiko : C
BIOSYN™ Monofilament Absorbable SutureFeb 1, 2025
Kelas Resiko : C
View all 126 products from this manufacturer →
31 Products
MICRA™ VR2Nov 11, 2024
Kelas Resiko : D
MICRA™ AV2Nov 11, 2024
Kelas Resiko : D
Evolut FX Loading SystemOct 18, 2024
Kelas Resiko : C
ENDURANT II Stent Graft SystemOct 2, 2024
Kelas Resiko : D
IN. PACT ADMIRAL Paclitaxel-coated PTA Balloon CatheterMay 6, 2024
Kelas Resiko : D
View all 31 products from this manufacturer →
30 Products
NEO Supra InstrumentFeb 7, 2025
Kelas Resiko : A
KANGHUI Implant SpineJan 30, 2025
Kelas Resiko : C
KANGHUI Variloc Pelvic InstrumentJan 6, 2025
Kelas Resiko : A
KANGHUI OMNAIL FEMORAL NAIL Instrument SetOct 9, 2024
Kelas Resiko : A
KANGHUI Omnail Femoral Nail KGD II Instrument SetNov 24, 2023
Kelas Resiko : A
View all 30 products from this manufacturer →
26 Products
MIRRO MRI DR SURESCAN DDME3D1Oct 4, 2024
Kelas Resiko : D
REVEAL LINQ ™Sep 20, 2024
Kelas Resiko : C
EVERA MRI S VR SureScanApr 22, 2024
Kelas Resiko : D
PRIMO MRI™ VR SureScan™Apr 7, 2024
Kelas Resiko : D
PRIMO MRI™ VR SureScan™Apr 7, 2024
Kelas Resiko : D
View all 26 products from this manufacturer →
VIANT MEDICAL INC.
United States
23 Products
DLP Retrograde Cannula-Auto Inflate-PVC BodyFeb 12, 2025
Kelas Resiko : C
BIO-MEDICUS Pediatric Arterial Cannula & ObturatorFeb 11, 2025
Kelas Resiko : C
BIOMEDICUS Percutaneous Kit, Multi Stage Veneous FemoralFeb 11, 2025
Kelas Resiko : C
STARFISH NS Heart PositionerFeb 8, 2025
Kelas Resiko : A
DLP Single Stage Venous CannulaFeb 4, 2025
Kelas Resiko : C
View all 23 products from this manufacturer →
COVIDIEN.
Ireland
18 Products
PURITAN BENNETT ™ 840 Ventilator SystemNov 26, 2024
Kelas Resiko : C
COVIDIEN Pediatric SomaSensor®Nov 14, 2024
Kelas Resiko : B
COVIDIEN OxyAlert NIRSensorNov 12, 2024
Kelas Resiko : B
COVIDIEN NELLCOR Adult SpO2 SensorMar 16, 2024
Kelas Resiko : B
COVIDIEN Somanetics Invos OximeterNov 29, 2023
Kelas Resiko : B
View all 18 products from this manufacturer →
18 Products
SPECIFY SURESCAN MRI 2X8 Lead KitNov 20, 2024
Kelas Resiko : D
VECTRIS 1x8 Subcompat Trial LeadOct 30, 2024
Kelas Resiko : D
CAPSURE ™ EPIMar 29, 2024
Kelas Resiko : D
MEDTRONIC Attain Ability PlusMar 29, 2024
Kelas Resiko : D
MEDTRONIC Attain PerformaMar 29, 2024
Kelas Resiko : D
View all 18 products from this manufacturer →
16 Products
MIRAGE ™ .008 Hydrophilic GuidewireJan 12, 2025
Kelas Resiko : C
Solitaire ™ X Revascularization DeviceMar 7, 2024
Kelas Resiko : C
REACT™ 71 CatheterMar 4, 2024
Kelas Resiko : C
PIPELINE Flex Embolization Device with Shield TechnologyJun 1, 2022
Kelas Resiko : D
Pipeline™ Vantage Embolization Device with Shield Technology™Dec 2, 2021
Kelas Resiko : D
View all 16 products from this manufacturer →
16 Products
CARPEDIEM BL250 Kit 0075 CVVHJun 4, 2022
Kelas Resiko : C
KABLP05 - KIT PEX X AMPLYAAug 14, 2021
Kelas Resiko : C
KABL14P05 - KIT CPFA X AMPLYAAug 11, 2021
Kelas Resiko : C
BELLCO Drainage BagJul 7, 2021
Kelas Resiko : B
BL640 KIT HFR 17 (HFR Evolution Therapy)May 5, 2021
Kelas Resiko : C
View all 16 products from this manufacturer →
12 Products
MEDTRONIC MYCARELINK SMART Patient ReaderNov 12, 2024
Kelas Resiko : B
MEDTRONIC CommunicatorOct 17, 2024
Kelas Resiko : C
MEDTRONIC Dual Chamber Temporary External PacemakerOct 10, 2024
Kelas Resiko : D
MEDTRONIC Patient ConnectorOct 9, 2024
Kelas Resiko : C
MEDTRONIC Patient ConnectorMar 19, 2024
Kelas Resiko : C
View all 12 products from this manufacturer →
12 Products
CROME™ VR MRI SureScan™Jan 24, 2022
Kelas Resiko : D
CROME™ VR MRI SureScan™Jan 24, 2022
Kelas Resiko : D
CROME™ DR MRI SureScan™Jan 24, 2022
Kelas Resiko : D
CROME™ HF CRT-D MRI SureScan™Jan 18, 2022
Kelas Resiko : D
CROME™ DR MRI SureScan™Jan 18, 2022
Kelas Resiko : D
View all 12 products from this manufacturer →
10 Products
EDM CathetersFeb 8, 2025
Kelas Resiko : C
EXACTFeb 8, 2025
Kelas Resiko : C
MEDTRONIC Manual Retraction KitApr 22, 2024
Kelas Resiko : D
MEDTRONIC Coaxial Umbilical CableDec 4, 2023
Kelas Resiko : D
BECKER External Drainage and Monitoring SystemNov 8, 2023
Kelas Resiko : C
View all 10 products from this manufacturer →
10 Products
MEDTRONIC Refill KitNov 23, 2024
Kelas Resiko : C
MEDTRONIC Catheter Access Port KitNov 18, 2024
Kelas Resiko : C
MEDTRONIC Patient Programmer TH91DSep 10, 2024
Kelas Resiko : D
MEDTRONIC Patient Programmer MRI SureScanDec 4, 2023
Kelas Resiko : D
PATIENT PROGRAMMER TH90DDec 29, 2022
Kelas Resiko : D
View all 10 products from this manufacturer →
MEDTRONIC INC.
United States
10 Products
MEDTRONIC Tunneling ToolJun 19, 2024
Kelas Resiko : A
ADJUSTABLE Valve 6248VALFeb 1, 2024
Kelas Resiko : B
MEDTRONIC OPEN PIVOT AP360 HEART VALVE AORTIC, Model 505DANov 28, 2023
Kelas Resiko : D
MEDTRONIC Open Pivot Heart Valve Sizer Set-576Oct 14, 2023
Kelas Resiko : B
MEDTRONIC Carelink ProgrammerOct 20, 2022
Kelas Resiko : D
View all 10 products from this manufacturer →
10 Products
BL640 KIT SUPRA 17Apr 20, 2021
Kelas Resiko : C
BL640 KIT SUPRA 13Apr 20, 2021
Kelas Resiko : C
BL640 KIT HFR AEQ – HFR17Apr 20, 2021
Kelas Resiko : C
ABL14P05 - Pre-assembled device for CPFA for AmplyaApr 6, 2021
Kelas Resiko : C
ABLP05 - Pre-assembled device for PEX for AmplyaApr 6, 2021
Kelas Resiko : C
View all 10 products from this manufacturer →
9 Products
MEDTRONIC XPS StraightShot M4 MicrodebriderJan 24, 2025
Kelas Resiko : B
ENT MR8™ Midas Rex Clearview™ ToolsJan 30, 2024
Kelas Resiko : B
MIDAS Rex Curved BurAug 28, 2023
Kelas Resiko : B
MEROCELAug 11, 2023
Kelas Resiko : A
NIM TRIVANTAGE EMG Endotracheal TubeAug 9, 2023
Kelas Resiko : B
View all 9 products from this manufacturer →
9 Products
DAR Guedel AirwayOct 28, 2024
Kelas Resiko : A
DAR HME for Tracheostomized PatientsFeb 14, 2024
Kelas Resiko : B
DAR Electrostatic FilterFeb 12, 2024
Kelas Resiko : B
DAR Infant Breathing CircuitApr 21, 2022
Kelas Resiko : A
DAR Adult Breathing CircuitJan 19, 2021
Kelas Resiko : A
View all 9 products from this manufacturer →
9 Products
AFFINITY AF 100 Arterial Filter with Balance BiosurfaceFeb 4, 2024
Kelas Resiko : B
AFFINITY NT OXYGENATOR WITH BALANCE BIOSURFACEFeb 1, 2024
Kelas Resiko : C
AFFINITY NT Oxygenator with Balance Biosurface & Uncoated Cardiotomy/Venous ReservoirJan 31, 2024
Kelas Resiko : C
BIO-PROBE Disposable Insert DP38 AdultSep 30, 2022
Kelas Resiko : C
LR-ACTNov 6, 2020
Kelas Resiko : C
View all 9 products from this manufacturer →
9 Products
PALINDROME Precision HSI Chronic Catheter and KitsDec 18, 2020
Kelas Resiko : C
PALINDROME SI Chronic Catheter and KitsDec 17, 2020
Kelas Resiko : C
PALINDROME H Chronic Catheter and KitsDec 17, 2020
Kelas Resiko : C
PALINDROME HSI Chronic Catheter and KitsDec 16, 2020
Kelas Resiko : C
MAHURKAR Elite Acute Triple Lumen Catheter and KitsDec 16, 2020
Kelas Resiko : C
View all 9 products from this manufacturer →
8 Products
SHILEY Lo-Contour Oral/Nasal Tracheal Tube Cuffed/ ReinforcedAug 27, 2024
Kelas Resiko : B
SHILEY Endobronchial Tube / LeftMar 17, 2021
Kelas Resiko : B
SHILEY™ Oral RAE Tracheal Tube Cuffless / Murphy EyeMar 6, 2021
Kelas Resiko : B
SHILEY™ Oral/Nasal Tracheal Tube Cuffless / ReinforcedFeb 25, 2021
Kelas Resiko : B
SHILEY Endobronchial Tube / RightDec 22, 2020
Kelas Resiko : B
View all 8 products from this manufacturer →
8 Products
CONTEGRA™ 200 Pulmonary Valved ConduitJul 5, 2024
Kelas Resiko : D
MEDTRONIC Hancock II Mitral ObturatorsJan 4, 2024
Kelas Resiko : B
HANCOCK II Aortic ObturatorsJul 4, 2021
Kelas Resiko : A
CONTEGRA 200 Pulmonary Valved Conduit (Unsupported)May 20, 2021
Kelas Resiko : D
MEDTRONIC Valve HandleDec 2, 2020
Kelas Resiko : A
View all 8 products from this manufacturer →
8 Products
MEDTRONIC DBS Tunneling Tool Accessory KitFeb 6, 2024
Kelas Resiko : D
INTELLIS™ Neurostimulation for Chronic PainJan 20, 2024
Kelas Resiko : D
SYNCHROMED II Infusion PumpDec 4, 2023
Kelas Resiko : D
MEDTRONIC Catheter PasserNov 28, 2023
Kelas Resiko : D
PERCEPT PC BrainSenseJul 22, 2022
Kelas Resiko : D
View all 8 products from this manufacturer →
8 Products
MEDTRONIC ENT MR8™ High-Speed Drill SystemJan 30, 2024
Kelas Resiko : B
MIDAS REX MR8 Drill System AttachmentsDec 8, 2023
Kelas Resiko : B
Midas Rex MR8 Drill System Surgical Dissecting ToolsSep 5, 2023
Kelas Resiko : B
MIDAS REX Drill System HandpiecesAug 29, 2023
Kelas Resiko : B
MIDAS REX MR8 Drill System HandpiecesAug 25, 2023
Kelas Resiko : B
View all 8 products from this manufacturer →
8 Products
MELODY Transcatheter Pulmonary ValveDec 28, 2023
Kelas Resiko : D
MEDTRONIC EVOLUT Pro Plus SystemDec 12, 2022
Kelas Resiko : D
BIO-MEDICUS Life Support Arterial Catheter (LS96010)Jun 11, 2022
Kelas Resiko : C
BIO-MEDICUS Life Support CatheterMay 24, 2022
Kelas Resiko : C
COREVALVE™ EVOLUT™ R Transcatheter Aortic ValveApr 2, 2022
Kelas Resiko : D
View all 8 products from this manufacturer →
8 Products
MEDTRONIC Autotransfusion Blood Collection Reservoir EL2120Nov 30, 2023
Kelas Resiko : B
MEDTRONIC Special Holding Bag 1000mlNov 17, 2023
Kelas Resiko : B
MEDTRONIC Suction and Anticoagulation AssemblyNov 8, 2023
Kelas Resiko : B
MEDTRONIC Autotransfusion Blood Collection ReservoirNov 8, 2023
Kelas Resiko : B
MEDTRONIC Cardiotomy ReservoirNov 3, 2023
Kelas Resiko : B
View all 8 products from this manufacturer →
8 Products
BL250 Kit 025 CVVH/CVVHDJun 7, 2022
Kelas Resiko : C
BL250 Kit 015 CVVH/CVVHDMay 28, 2022
Kelas Resiko : C
BL250 Pre-assembled Device for Neonatal and Pediatric Hemofiltration/HemodialysisDec 14, 2021
Kelas Resiko : C
CARPEDIEMNov 30, 2021
Kelas Resiko : C
BELLCO Blood and Infusion lines for extracorporeal circulationOct 27, 2020
Kelas Resiko : C
View all 8 products from this manufacturer →
7 Products
X-PEDION Hydrophilic GuidewireJan 12, 2025
Kelas Resiko : C
REBAR -27 Micro CatheterMay 26, 2022
Kelas Resiko : C
HYPERGLIDE Occlusion Balloon SystemMay 25, 2022
Kelas Resiko : B
CONCERTO™ Detachable Coil System – PGLA FiberApr 7, 2021
Kelas Resiko : D
AXIUM Detachable Coil SystemMar 25, 2021
Kelas Resiko : D
View all 7 products from this manufacturer →
7 Products
WEM Microprocessed Electrosurgical Unit Model SS-501SXOct 30, 2024
Kelas Resiko : C
ARGON ElectrodeApr 23, 2022
Kelas Resiko : C
WEM Bipolar ForcepsMar 17, 2021
Kelas Resiko : C
WEM Monopolar ForcepsFeb 25, 2021
Kelas Resiko : C
WEM Electrosurgical ElectrodeFeb 25, 2021
Kelas Resiko : C
View all 7 products from this manufacturer →
7 Products
ACTIVE SCFeb 17, 2024
Kelas Resiko : D
ACTIVATE PCFeb 17, 2024
Kelas Resiko : D
ASCENDA Intratechal Catheter 73 cm Pump Segment Revision KitNov 28, 2023
Kelas Resiko : D
ASCENDA Intrathecal Catheter with an 66 cm Spinal SegmentNov 24, 2023
Kelas Resiko : D
SENSIGHT Extension Tunneler KitOct 31, 2022
Kelas Resiko : B
View all 7 products from this manufacturer →
6 Products
MINIMED RESERVOIRDec 12, 2024
Kelas Resiko : B
CAPSUREFIX NOVUSMar 29, 2024
Kelas Resiko : D
MEDTRONIC CapSure Sense MRI SureScanMar 29, 2024
Kelas Resiko : B
ARCTIC FRONT ADVANCE™ Cardiac CryoAblation CatheterDec 7, 2021
Kelas Resiko : D
SELECTSECURE MRI SureScanOct 13, 2021
Kelas Resiko : D
View all 6 products from this manufacturer →
6 Products
CD HORIZON Spinal SystemJun 6, 2024
Kelas Resiko : C
DIVERGENCE Anterior Cervical Fusion SystemDec 14, 2023
Kelas Resiko : C
TIMESH SystemNov 22, 2022
Kelas Resiko : C
CRESCENT Spinal SystemAug 31, 2021
Kelas Resiko : C
CAPSTONE PTC™ Spinal SystemNov 4, 2020
Kelas Resiko : C
View all 6 products from this manufacturer →
6 Products
MEDTRONIC Paradigm Insulin PumpDec 30, 2020
Kelas Resiko : B
MEDTRONIC Paradigm Insulin Pump-MMT-515Dec 15, 2020
Kelas Resiko : B
MEDTRONIC Paradigm Insulin Pump-MMT-715Dec 7, 2020
Kelas Resiko : B
PARADIGM Insulin Pump-MMT 522Dec 1, 2020
Kelas Resiko : B
PRIMEADVANCED Surescan MRINov 19, 2020
Kelas Resiko : D
View all 6 products from this manufacturer →
MEDTRONIC VASCULAR
United States
5 Products
EXPORT ADVANCE Aspiration CatheterAug 1, 2024
Kelas Resiko : C
EXPORT™ APOct 25, 2022
Kelas Resiko : C
EXPORT ADVANCE™ Aspiration CatheterSep 27, 2022
Kelas Resiko : C
MEDTRONIC Angiographic Guide WireSep 24, 2020
Kelas Resiko : C
EXPORT AP Aspiration CatheterNov 1, 2019
Kelas Resiko : C
5 Products
FREEZOR Xtra Cardiac Cryoablation CathetersDec 6, 2023
Kelas Resiko : D
FREEZOR Cardiac Cryoablation CathetersOct 25, 2023
Kelas Resiko : D
FREEZOR MAX Cardiac Cryoablation CathetersOct 25, 2023
Kelas Resiko : D
ARCTIC FRONT ADVANCE PROOct 25, 2023
Kelas Resiko : D
FLEXCATH ADVANCE™Sep 1, 2021
Kelas Resiko : C
5 Products
COVIDIEN 4K/UHD LaparoscopeDec 30, 2022
Kelas Resiko : B
COVIDIEN 4K/UHD ArthroscopeDec 19, 2022
Kelas Resiko : B
COVIDIEN Otoskop (Otoscope)Apr 5, 2022
Kelas Resiko : B
COVIDIEN Nasoskop (Sinuscope)Mar 30, 2022
Kelas Resiko : B
COVIDIEN Zystoskop (Cystoscope)Mar 9, 2022
Kelas Resiko : B
5 Products
MINIMED™ Silhouette Infusion Set, SC1Jun 17, 2022
Kelas Resiko : C
MINIMED™ Mio Infusion Set, SC1Jun 17, 2022
Kelas Resiko : C
MINIMED™ Quick Set Infusion Set, SC1Jun 14, 2022
Kelas Resiko : C
MINIMED™ Sure T Infusion Set, SC1Jun 5, 2022
Kelas Resiko : C
QUICK-SET Infusion SetMay 29, 2020
Kelas Resiko : C
5 Products
MEDTRONIC Single Chamber Temporary External Pacemaker 53401May 20, 2022
Kelas Resiko : D
CARELINK ENCORE ProgrammerApr 19, 2021
Kelas Resiko : D
MEDTRONIC MyCareLink Patient MonitorJul 23, 2020
Kelas Resiko : B
MEDTRONIC CareLink Express MonitorFeb 3, 2020
Kelas Resiko : B
MEDTRONIC CareLink Express MonitorFeb 3, 2020
Kelas Resiko : B
5 Products
Axium™ Prime Detachable Coil SystemJul 30, 2021
Kelas Resiko : D
AXIUM™ Detachable Coil System (PGLA)Jul 1, 2021
Kelas Resiko : D
AXIUM™ Detachable Coil SystemJun 11, 2021
Kelas Resiko : D
AXIUM™ Detachable Coil System (Nylon)Jun 11, 2021
Kelas Resiko : D
SPRINTER LEGEND OTW Balloon Dilatation CatheterJul 22, 2020
Kelas Resiko : C
5 Products
COVIDIEN Electrosurgery Reusable Hand Instruments and AccessoriesFeb 15, 2021
Kelas Resiko : C
COVIDIEN Reusable ObturatorFeb 11, 2021
Kelas Resiko : C
COVIDIEN Suction IrrigationFeb 8, 2021
Kelas Resiko : B
ETH-Needle HolderFeb 4, 2021
Kelas Resiko : B
COVIDIEN Trocar With Silicon Valve, DismountableJan 1, 2021
Kelas Resiko : B
EV3, INC.
United States
4 Products
PROTEGE GPS Self-expanding Peripheral StentSep 30, 2024
Kelas Resiko : C
VISI-PRO Balloon-Expandable Peripheral Stent SystemAug 1, 2023
Kelas Resiko : D
PARAMOUNT Mini GPS Balloon – Expandable Biliary Stent SystemJan 22, 2021
Kelas Resiko : C
INTRASTENT™ LD MEGA™ Large Diameter Peripheral StentDec 1, 2020
Kelas Resiko : C
4 Products
LOSSNov 21, 2023
Kelas Resiko : C
MEDTRONIC Ventricular CathetersMay 17, 2020
Kelas Resiko : C
OPUSMay 15, 2020
Kelas Resiko : C
PASSERSApr 28, 2020
Kelas Resiko : C
4 Products
TIMESH SystemJan 25, 2023
Kelas Resiko : C
DELTA Shunt KitMar 19, 2020
Kelas Resiko : C
MEDTRONIC External Drainage and Monitoring Ventricular CatheterDec 12, 2019
Kelas Resiko : C
MEDTRONIC CSF-Unitized ShuntsNov 19, 2019
Kelas Resiko : C
4 Products
LIGASURE Dolphin TipMar 30, 2021
Kelas Resiko : C
LIGASURE ATLAS™ Tissue FusionMar 23, 2021
Kelas Resiko : C
LIGASURE Curved, Small Jaw, Open Sealer/Divider 16.5 mm - 19 cmMar 17, 2021
Kelas Resiko : C
LIGASURE™ Curved Jaw, Open Sealer/DividerMar 6, 2021
Kelas Resiko : C
4 Products
ACT Easy Fill DeviceOct 12, 2020
Kelas Resiko : A
MEDTRONIC HR-HTCSep 9, 2020
Kelas Resiko : B
MEDTRONIC RACTSep 4, 2020
Kelas Resiko : C
MEDTRONIC HR-ACT Temperature CatridgesSep 2, 2020
Kelas Resiko : C
3 Products
BIO-MEDICUS Pediatric Insertion KitFeb 11, 2025
Kelas Resiko : C
BIO-MEDICUS™ Adult Venous Cannula KitsFeb 8, 2023
Kelas Resiko : C
BIO-MEDICUS Arterial Insertion KitNov 10, 2020
Kelas Resiko : C
3 Products
PROTEGE RX Self-expanding Carotid Stent SystemJan 13, 2025
Kelas Resiko : D
PROTEGE™ GPS™ Self-expanding Peripheral Stent SystemSep 20, 2024
Kelas Resiko : D
Fortrex™ HP PTA Balloon CatheterDec 19, 2023
Kelas Resiko : C
3 Products
AVALUS Bioprothesis Model 400Jan 4, 2025
Kelas Resiko : D
NC EUPHORA Rapid Exchange Balloon Dilatation CatheterSep 20, 2023
Kelas Resiko : C
EUPHORA Rapid Exchange Balloon Dilatation CatheterSep 15, 2023
Kelas Resiko : C
3 Products
RELIANT Button Switch Pencil HolsterNov 22, 2024
Kelas Resiko : C
CLEANCOAT™ Laparoscopic Curved Spatula Electrode CoatedFeb 25, 2021
Kelas Resiko : C
VALLEYLAB™Laparoscopic Electrode, SolidFeb 8, 2021
Kelas Resiko : C
3 Products
MEDTRONIC SEXTANT II Reusable InstrumentOct 31, 2024
Kelas Resiko : A
MEDTRONIC Reusable Instrument & AccessoriesJun 7, 2024
Kelas Resiko : A
MEDTRONIC Orthopedic Manual Surgical InstrumentFeb 27, 2024
Kelas Resiko : A
3 Products
ATTAIN Stability Quad MRI SureScan 4798Oct 16, 2024
Kelas Resiko : D
SPRINT QUATTRO SECURE SMar 18, 2024
Kelas Resiko : D
MEDTRONIC Subcutaneous Lead SystemJul 1, 2019
Kelas Resiko : D
EV3 INC.
United States
3 Products
TRAILBLAZER Support CatheterSep 30, 2024
Kelas Resiko : C
AMPLATZ GOOSE NECK Microsnare and KitMar 7, 2022
Kelas Resiko : C
EVERCROSS™ .035" OTW PTA Dilatation CatheterDec 29, 2020
Kelas Resiko : C
3 Products
FLEXCATH ADVANCE ™Aug 28, 2024
Kelas Resiko : C
MEDTRONIC CryoConsole SystemDec 19, 2023
Kelas Resiko : D
ARCTIC FRONT ADVANCE Cardiac CryoAblation CatheterOct 18, 2023
Kelas Resiko : D
3 Products
DxTERITY Diagnostic Angiography CatheterAug 19, 2024
Kelas Resiko : C
EVEREST 20 Survival KitJul 3, 2020
Kelas Resiko : B
MULLINS Transseptal Catheter IntroducerDec 6, 2019
Kelas Resiko : B
3 Products
TIPVISION VideoscopeJan 29, 2024
Kelas Resiko : B
FlexiLux 200 LED, LED light source with Multi light guide adapterApr 2, 2020
Kelas Resiko : B
Flexilux II LaparoscopeMay 31, 2019
Kelas Resiko : B
3 Products
MEDTRONIC STEALTHSTATION S8Jan 20, 2024
Kelas Resiko : B
Stealth Autoguide SystemOct 4, 2022
Kelas Resiko : B
MEDTRONIC StealthStation FlexENT™Nov 18, 2021
Kelas Resiko : B
3 Products
MEDTRONIC Catheter Connecting CableOct 17, 2023
Kelas Resiko : C
THUNDER GuidewiresSep 12, 2023
Kelas Resiko : C
PROVIA Steerable GuidewireNov 19, 2019
Kelas Resiko : C
MEDTRONIC XOMED INC
United States
3 Products
ENDO-SCRUB® 2 SHEATHJul 26, 2023
Kelas Resiko : B
MEDTRONIC NERVE Monitoring SystemMar 30, 2021
Kelas Resiko : B
MEDTRONIC XOMED Ventilation TubesApr 14, 2020
Kelas Resiko : C
3 Products
PROGRIP Self-Gripping Polypropylene MeshMay 19, 2023
Kelas Resiko : B
PARIETENE Flat Sheet Mesh and Lightweight MeshApr 19, 2023
Kelas Resiko : B
PARIETEX™ Hydrophilic MeshApr 6, 2023
Kelas Resiko : B
3 Products
HYSTEROLUX Fluid Management SystemNov 18, 2022
Kelas Resiko : B
COVIDIEN Insufflator 50L and AccessoriesMay 10, 2022
Kelas Resiko : B
COVIDIEN InsufflatorFeb 25, 2021
Kelas Resiko : B
3 Products
INSPIRED™ Auto-feed Humidification ChamberMar 30, 2022
Kelas Resiko : B
INSPIRED Ventilator HumidifierFeb 23, 2022
Kelas Resiko : B
INSPIRED Heated Breathing CircuitJan 10, 2022
Kelas Resiko : B
3 Products
MEDTRONIC MINIMED Quick SerterNov 19, 2020
Kelas Resiko : B
MEDTRONIC Sil SerterMar 6, 2020
Kelas Resiko : B
MEDTRONIC Quick SerterFeb 12, 2020
Kelas Resiko : B
3 Products
iPort Advance ™ Injection PortApr 15, 2020
Kelas Resiko : C
SILHOUETTE PARADIGMOct 29, 2019
Kelas Resiko : C
SILHOUETTE PARADIGM ShortOct 28, 2019
Kelas Resiko : C
2 Products
ATLANTIS Anterior Cervical Plate SystemFeb 12, 2025
Kelas Resiko : C
CD HORIZON Spinal SystemFeb 6, 2025
Kelas Resiko : C
2 Products
TRI-AD 2.0 Adams Tricuspid BandFeb 6, 2025
Kelas Resiko : D
TRI-AD 2.0 Adams Tricuspid BandNov 29, 2020
Kelas Resiko : C
2 Products
MEDTRONIC Integrated Power Console (IPC) NTJan 24, 2025
Kelas Resiko : B
MEDTRONIC NIM-ECLIPSE ControllerMay 24, 2020
Kelas Resiko : B
2 Products
STREAMLINE Unipolar Temporary Myocardial Pacing LeadJan 14, 2025
Kelas Resiko : B
STREAMLINE Unipolar Pediatric Temporary Pacing LeadOct 6, 2020
Kelas Resiko : C
2 Products
NELLCOR™ Bedside SpO2 Patient Monitoring SystemNov 23, 2024
Kelas Resiko : B
NELLCOR Portable SpO2 Patient Monitoring SystemApr 21, 2022
Kelas Resiko : B
2 Products
MEDTRONIC TRIMLINE Reuseable InstrumentOct 29, 2024
Kelas Resiko : A
MEDTRONIC DIVERGENCE Reusable InstrumentJan 5, 2024
Kelas Resiko : A
2 Products
CAPSURE SENSE MRI SURESCAN LeadOct 2, 2024
Kelas Resiko : D
REVEAL LINQ Insertable Cardiac MonitorOct 1, 2024
Kelas Resiko : C
EV3 INC
United States
2 Products
NANOCROSS Elite 0.014Sep 30, 2024
Kelas Resiko : C
AMPLATZ Goose Neck Snare and KitMar 15, 2022
Kelas Resiko : C
2 Products
CAPSTONE SPINAL SYSTEMSep 12, 2024
Kelas Resiko : C
CAPSTONE PTC ™ SPINAL SYSTEMAug 30, 2024
Kelas Resiko : C
2 Products
MEDTRONIC Catheter Connecting CableAug 4, 2024
Kelas Resiko : C
CARDIOBLATE BP2 Ablation DeviceSep 28, 2020
Kelas Resiko : C
2 Products
GAUTHIER Orthopedic Manual Surgical Instrument - 1Jun 19, 2024
Kelas Resiko : A
GAUTHIER Orthopedic Manual Surgical Instrument - 2Jun 12, 2024
Kelas Resiko : A
2 Products
CD Horizon Spinal System (Warsaw)Jun 3, 2024
Kelas Resiko : C
MEDTRONIC Reusable Instrument & Accessories (Warsaw)Mar 24, 2024
Kelas Resiko : A
2 Products
MICRA Introducer Sheath with Hydrophilic CoatingMar 29, 2024
Kelas Resiko : B
SENTRANT Introducer Sheath with Hydrophilic CoatingSep 2, 2023
Kelas Resiko : B
2 Products
MEDTRONIC AVALUS SizersDec 28, 2023
Kelas Resiko : B
MEDTRONIC VALVE HANDLEDec 2, 2020
Kelas Resiko : A
2 Products
TRUCLEAR ™ Hysteroscope Set DuoOct 14, 2023
Kelas Resiko : B
TruClear Operative HysteroscopesMay 19, 2022
Kelas Resiko : B
2 Products
INTUITION Steerable Guidewire Hydro-TrackSep 12, 2023
Kelas Resiko : C
INTUITION Steerable Guidewire Pro/PelSep 12, 2023
Kelas Resiko : C
2 Products
ADMIRAL XTREME PTA Balloon CatheterAug 11, 2023
Kelas Resiko : C
PACIFIC XTREME PTA Balloon CatheterJun 16, 2020
Kelas Resiko : C
2 Products
VALLEYLAB™ Telescoping Smoke Evacuation Rocker Switch Pencil Edge™ Blade ElectrodeSep 2, 2022
Kelas Resiko : C
VALLEYLAB™ Smoke AttachmentMay 1, 2021
Kelas Resiko : B
2 Products
W.O.M. Laparoscopy Pump (LAP-Pump) and AccessoriesMay 16, 2022
Kelas Resiko : B
COVIDIEN InsufflatorFeb 25, 2021
Kelas Resiko : B
2 Products
TRUCLEAR Hysteroscopic Tissue Removal SystemMay 9, 2022
Kelas Resiko : B
SURGISLEEVE Wound ProtectorApr 19, 2022
Kelas Resiko : B
2 Products
KANGHUI ECO ImplantDec 31, 2021
Kelas Resiko : C
KANGHUI ECO Orthopedic InstrumentDec 21, 2021
Kelas Resiko : A
2 Products
CRAGG-MCNAMARA™ 5F Valved Infusion CatheterMay 5, 2021
Kelas Resiko : C
CRAGG-MCNAMARA™ 4F Valved Infusion CatheterMay 1, 2021
Kelas Resiko : C
2 Products
VALLEYLAB™ Ball ElectrodesFeb 1, 2021
Kelas Resiko : C
VALLEYLAB™ Tungsten Loop ElectrodesDec 30, 2020
Kelas Resiko : C
MEDTRONIC MINIMED.
United States
2 Products
ENLITE Glucose SensorJan 1, 2021
Kelas Resiko : C
iPro 2 Professional CGM SystemApr 17, 2020
Kelas Resiko : C
2 Products
SURE-T ParadigmNov 25, 2020
Kelas Resiko : C
MIO Infusion SetApr 15, 2020
Kelas Resiko : C
2 Products
MEDTRONIC External NeustimulatorNov 12, 2020
Kelas Resiko : B
N'VISION Clinician ProgrammerOct 14, 2020
Kelas Resiko : C
MEDTRONIC MINIMED
United States
2 Products
ENLITE Serter- MMT 7510May 6, 2020
Kelas Resiko : C
GUARDIAN REAL-Time Continuous Glucose Monitoring SystemApr 20, 2020
Kelas Resiko : C
2 Products
MEDTRONIC Restore Sensor SureScanJan 28, 2020
Kelas Resiko : B
MEDTRONIC Restore Advance SureScanAug 13, 2019
Kelas Resiko : B
1 Products
BIS™ Advance MonitorFeb 12, 2025
Kelas Resiko : B
1 Products
NG BIO-MEDICUS ™ Adult Venous Cannula and IntroducerFeb 4, 2025
Kelas Resiko : C
1 Products
FUSION COMPACT™ ENT NAVIGATION SYSTEMFeb 1, 2025
Kelas Resiko : B
1 Products
MEDTRONIC StealthStation S7 Navigation SystemJan 24, 2025
Kelas Resiko : B
1 Products
AQUAMANTYS SealerJan 23, 2025
Kelas Resiko : C
1 Products
MEDTRONIC PSO Reusable InstrumentsJan 2, 2025
Kelas Resiko : A
1 Products
AUTOLOGOUS IQ™Jan 2, 2025
Kelas Resiko : B
1 Products
BIS Complete Monitoring SystemDec 19, 2024
Kelas Resiko : B
1 Products
CELESTICA Electroencephalograph ElectrodeNov 25, 2024
Kelas Resiko : B
1 Products
COVIDIEN Nellcor™ SpO2 Module, Interface Cable IncludedNov 23, 2024
Kelas Resiko : B
1 Products
Nellcor™ Bedside Respiratory Patient Monitoring SystemNov 23, 2024
Kelas Resiko : B
1 Products
VALLEYLAB Bayonet ForcepsNov 14, 2024
Kelas Resiko : A
1 Products
MEDTRONIC MRC Reusable InstrumentNov 5, 2024
Kelas Resiko : A
1 Products
MAST QUADRANT Retractor SystemOct 29, 2024
Kelas Resiko : A
1 Products
BE-ST Pedicle Access NeedleOct 28, 2024
Kelas Resiko : C
1 Products
MEDTRONIC Lead End Cap KitOct 13, 2024
Kelas Resiko : A
1 Products
MEDTRONIC Pin Plug KitOct 13, 2024
Kelas Resiko : A
1 Products
CAPSUREFIX NOVUSOct 10, 2024
Kelas Resiko : D
1 Products
MEDTRONIC Adjustable SlitterOct 1, 2024
Kelas Resiko : A
LAKE REGION MEDICAL
United States
1 Products
ACHIEVE ADVANCE Mapping CatheterAug 19, 2024
Kelas Resiko : C
1 Products
MCGRATH MAC Video LaryngoscopeJul 31, 2024
Kelas Resiko : A
1 Products
AURORA EV-ICD™ MRI SureScan™Jul 29, 2024
Kelas Resiko : D
1 Products
INVOS Adult rSO2 Sensor and AccessoriesJul 7, 2024
Kelas Resiko : B
1 Products
COVIDIEN Single Incision Laparoscopic Surgery (SILS)Jun 19, 2024
Kelas Resiko : B
1 Products
MICROMAR EasyDrill Cranial PerforatorApr 29, 2024
Kelas Resiko : B
MEDTRONIC INC
United States
1 Products
ABRE Venous Self-expanding Stent SystemApr 24, 2024
Kelas Resiko : D
1 Products
ATTAIN ABILITYMar 18, 2024
Kelas Resiko : D
1 Products
MEDTRONIC Reusable Instrument & Accessories (Puerto Rico)Mar 18, 2024
Kelas Resiko : A
1 Products
MEDTRONIC Micra MC1VR01 Transcatheter Pacing SystemFeb 6, 2024
Kelas Resiko : D
1 Products
SPHERA SR MRI SureScanFeb 6, 2024
Kelas Resiko : D
1 Products
ELEVISION HD 2 CCU Image and Video RECFeb 2, 2024
Kelas Resiko : B
1 Products
WRENCH Kit 5873WFeb 1, 2024
Kelas Resiko : A
1 Products
EleVision HD 2 CCU Image RECJan 27, 2024
Kelas Resiko : B
1 Products
VERTE STACK Spinal System CrescentDec 15, 2023
Kelas Resiko : C
1 Products
PROFILE 3D™ Sizer Set 7680SNov 27, 2023
Kelas Resiko : A
1 Products
HANCOCK II T505Nov 14, 2023
Kelas Resiko : D
1 Products
INDERMIL® flexifuze™ Topical Tissue AdhesiveNov 14, 2023
Kelas Resiko : C
1 Products
SHILEY™ Endobronchial Tube/LeftNov 13, 2023
Kelas Resiko : B
VIANT MEDICAL, INC.
United States
1 Products
MC2 Two Stage Veneous CannulaOct 25, 2023
Kelas Resiko : C
1 Products
INVOS™ PM7100 Patient MonitorOct 4, 2023
Kelas Resiko : B
1 Products
TruClear Tissue Removal ShaverSep 26, 2023
Kelas Resiko : B
1 Products
ONYX TruStar Zotarolimus-Eluting Coronary Stent SystemSep 7, 2023
Kelas Resiko : D
1 Products
RADIANT Balloon Expandable Covered StentSep 7, 2023
Kelas Resiko : D
1 Products
MEDTRONIC Aortic PunchAug 25, 2023
Kelas Resiko : A
1 Products
MIDAS REX MR8 Clearview Surgical Dissecting ToolsAug 23, 2023
Kelas Resiko : B
1 Products
Cutter Driver for the HawkOne™ Directional Atherectomy SystemAug 21, 2023
Kelas Resiko : B
MEDTRONIC
Ireland
1 Products
MEDTRONIC HawkOne™ Directional Atherectomy SystemAug 15, 2023
Kelas Resiko : B
1 Products
COVIDIEN Parietene DS Composite MeshJul 20, 2023
Kelas Resiko : B
1 Products
MEDTRONIC WIRELESS EXTERNAL NEUROSTIMULATORJul 12, 2023
Kelas Resiko : D
1 Products
CALIMA BLOWER 220-240VJul 7, 2023
Kelas Resiko : B
1 Products
PROGRIP Self-Gripping Polyester MeshJun 25, 2023
Kelas Resiko : B
1 Products
MEDTRONIC UNIVERSAL II Slitter 6230UNIJun 19, 2023
Kelas Resiko : A
1 Products
AZURE XT DR MRI SureScanJun 8, 2023
Kelas Resiko : D
1 Products
HAZEMay 10, 2023
Kelas Resiko : B
1 Products
MEDTRONIC Brockenbrough Curved NeedleMar 6, 2023
Kelas Resiko : B
1 Products
INSPIRED Ventilation Breathing CircuitDec 5, 2022
Kelas Resiko : B
1 Products
AMPHIRION™ Deep PTA CatheterOct 27, 2022
Kelas Resiko : C
1 Products
SOLITAIRE AB Neurovascular Remodeling DeviceAug 4, 2022
Kelas Resiko : D
1 Products
MCGRATH X BLADE X3 Disposable Laryngoscope BladeAug 1, 2022
Kelas Resiko : A
VITALTEC CORPORATION
Taiwan (China)
1 Products
MCGRATH MAC Disposable Laryngoscope BladeJun 23, 2022
Kelas Resiko : A
COVIDIEN LLC.
United States
1 Products
FORTREX 0.035" OTW PTA Balloon CatheterMay 28, 2022
Kelas Resiko : C
EV3, Inc.
United States
1 Products
RAPIDCROSS™ PTA Rapid Exchange Balloon Dilatation CatheterMay 26, 2022
Kelas Resiko : C
SANMINA HUNTSVILLE
United States
1 Products
CAPNOSTREAM 35 Portable Respiratory MonitorMay 23, 2022
Kelas Resiko : C
1 Products
MARKSMAN CatheterMay 22, 2022
Kelas Resiko : C
1 Products
TRUCLEAR Elite HysteroscopesMay 12, 2022
Kelas Resiko : B
1 Products
INVOS PM7100 Patient Monitor and AccessoriesApr 27, 2022
Kelas Resiko : B
1 Products
VALLEYLAB™ REM Adult Universal Patient Return ElectrodeApr 23, 2022
Kelas Resiko : C
1 Products
SURGINEEDLE™ Auto Suture™ Insufflation NeedleApr 20, 2022
Kelas Resiko : B
1 Products
VALLEYLAB™ Smoke Evacuation PencilApr 20, 2022
Kelas Resiko : C
1 Products
MICROSTREAM™ Advance Filter LinesMar 23, 2022
Kelas Resiko : C
1 Products
MICROSTREAM™ Advance Filter and Luer Sampling LinesMar 22, 2022
Kelas Resiko : C
1 Products
HISERN Disposable Anesthesia MaskMar 16, 2022
Kelas Resiko : A
1 Products
HISERN Disposable Anesthesia Breathing CircuitMar 9, 2022
Kelas Resiko : A
1 Products
PHENOM™ CathetersMar 9, 2022
Kelas Resiko : C
1 Products
SHILEY™ Endobronchial Tube Left with Carinal HookDec 20, 2021
Kelas Resiko : B
1 Products
ACTIVE RCSep 16, 2021
Kelas Resiko : D
PMC, LLC
United States
1 Products
STRATA II Adjusment KitAug 21, 2021
Kelas Resiko : C
1 Products
MEDTRONIC Percutaneous Lead IntroducerJul 28, 2021
Kelas Resiko : B
1 Products
MICROSTREAM Advance Filter and Luer Sampling LinesJul 26, 2021
Kelas Resiko : C
1 Products
LAUNCHER Guiding CatheterJul 15, 2021
Kelas Resiko : C
1 Products
CONCERTO™ Detachable Coil System (PGLA)Jul 9, 2021
Kelas Resiko : D
1 Products
Valleylab™ Laparoscopic Smoke Evacuation System Active, PassiveMay 5, 2021
Kelas Resiko : B
EMBLATION LIMITED
United Kingdom
1 Products
EMPRINT™ Ablation Generator with THERMOSPHERE™ TechnologyMay 1, 2021
Kelas Resiko : C
1 Products
ATTAIN Venogram Balloon CatheterApr 19, 2021
Kelas Resiko : C
OSCOR INC
United States
1 Products
SAFESHEATH II Introducer SystemApr 16, 2021
Kelas Resiko : B
1 Products
CONFIDA Brecker GuidewireApr 13, 2021
Kelas Resiko : C
1 Products
HBIOFLUIDS Haemofiltration and Dialysis SolutionMar 30, 2021
Kelas Resiko : C
1 Products
HBIOFLUIDS Sodium Citrate SolutionMar 30, 2021
Kelas Resiko : C
1 Products
SHILEY Hi-Lo Hand Pressure GaugeMar 25, 2021
Kelas Resiko : B
1 Products
SHILEY™ Oral/Nasal Tracheal Tube Cuffless, Murphy EyeMar 17, 2021
Kelas Resiko : B
1 Products
SHILEY Speaking ValveMar 6, 2021
Kelas Resiko : B
1 Products
CELLO Balloon Guide Catheter, Intravascular Catheter with CuffMar 3, 2021
Kelas Resiko : C
1 Products
ARGYLE™ Safety Fistula Cannula with Anti-Reflux ValveFeb 9, 2021
Kelas Resiko : C
PLEXUS CORP.
United States
1 Products
CLOSURERFG Radiofrequency GeneratorFeb 9, 2021
Kelas Resiko : C
1 Products
VALLEYLAB™ Micro-Needle ElectrodeFeb 3, 2021
Kelas Resiko : C
1 Products
CLOSURERFS Endovenous Radiofrequency StyletFeb 3, 2021
Kelas Resiko : C
1 Products
COVIDIEN Electrosurgery Instruments and AccessoriesFeb 1, 2021
Kelas Resiko : C
1 Products
KENDALL Sterile Water for Inhalation USP with O2 Humidifier Adapter, 325 mlJan 1, 2021
Kelas Resiko : B
1 Products
SHILEY Adult Flexible Tracheostomy Tube with Taperguard Cuff, Reusable Inner CannulaDec 22, 2020
Kelas Resiko : B
1 Products
McGRATH MAC Video LaryngoscopeDec 18, 2020
Kelas Resiko : A
1 Products
BIO-MEDICUS Venous Insertion KitDec 4, 2020
Kelas Resiko : C
1 Products
CONTOUR 3D Sizer Set 7690SDec 3, 2020
Kelas Resiko : A
1 Products
MAHURKAR Elite Acute Dual Catheter and KitsNov 26, 2020
Kelas Resiko : C
COVIDIEN LLC
Thailand
1 Products
SHILEY™ Hi-Contour Oral/Nasal Tracheal Tube Cuffed Murphy EyeNov 26, 2020
Kelas Resiko : B
1 Products
FORCE FX™ Electrosurgical Generator 8CS 240 VOct 16, 2020
Kelas Resiko : C
BUFFALO FILTER LLC.
United States
1 Products
RAPIDVAC Smoke EvacuatorOct 8, 2020
Kelas Resiko : B
1 Products
VALLEYLAB LS Series Single Channel Vessel SealingOct 7, 2020
Kelas Resiko : C
1 Products
SAFE SHEATH (HLS series)Sep 12, 2020
Kelas Resiko : B
HEARTWARE, INC.
United States
1 Products
HEARTWARE WHAT CONTROLLERAug 11, 2020
Kelas Resiko : D
1 Products
REVEAL XTAug 7, 2020
Kelas Resiko : C
1 Products
SOLUCART PlusAug 3, 2020
Kelas Resiko : C
1 Products
MEDTRONIC Tunneling ToolJun 24, 2020
Kelas Resiko : A
1 Products
MEDTRONIC Reusable InstrumentJun 23, 2020
Kelas Resiko : A
1 Products
PACIFIC Plus PTA CatheterJun 16, 2020
Kelas Resiko : C
1 Products
MEDTRONIC MIDAS REX EHS SystemMay 17, 2020
Kelas Resiko : B
1 Products
QUICK-SET PARADIGM Infusion SetApr 17, 2020
Kelas Resiko : C
1 Products
MAHURKAR Acute Dual Lumen Catheters and KitsMar 9, 2020
Kelas Resiko : C
1 Products
SHILEY Laryngeal MaskJan 21, 2020
Kelas Resiko : A
1 Products
INPUT TS Introducer SheathNov 29, 2019
Kelas Resiko : B
1 Products
MEDTRONIC Divergence Instrument- SterileOct 28, 2019
Kelas Resiko : A
1 Products
AMPHIRION DEEP PTA Balloon CatheterSep 6, 2019
Kelas Resiko : C
1 Products
Camera Head Full HD ZoomMay 31, 2019
Kelas Resiko : B
All represented products (786)

Complete portfolio registered with BPOM

BIS™ Advance MonitorFeb 12, 2025
Manufacturer: JABIL CIRCUIT SINGAPORE PTE LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ATLANTIS Anterior Cervical Plate SystemFeb 12, 2025
Manufacturer: MEDTRONIC SOFAMOR DANEK MANUFACTURING
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Retrograde Cannula-Auto Inflate-PVC BodyFeb 12, 2025
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-MEDICUS Pediatric Arterial Cannula & ObturatorFeb 11, 2025
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-MEDICUS Pediatric Insertion KitFeb 11, 2025
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIOMEDICUS Percutaneous Kit, Multi Stage Veneous FemoralFeb 11, 2025
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EDM CathetersFeb 8, 2025
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EXACTFeb 8, 2025
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STARFISH NS Heart PositionerFeb 8, 2025
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
NEO Supra InstrumentFeb 7, 2025
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
V-LOC™ PBT Non-Absorbable Wound Closure DeviceFeb 7, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TRI-AD 2.0 Adams Tricuspid BandFeb 6, 2025
Manufacturer: MEDTRONIC MEXICO S DE R.L DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CD HORIZON Spinal SystemFeb 6, 2025
Manufacturer: MEDTRONIC SOFAMOR DANEK MANUFACTURING
Class: Kelas : 2
Risk Class: Kelas Resiko : C
APPOSE ULC Auto Suture Slim Body Skin StaplerFeb 5, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO GIA Ultra Universal StaplerFeb 5, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Plain Gut Absorbable SutureFeb 5, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Single Stage Venous CannulaFeb 4, 2025
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NG BIO-MEDICUS ™ Adult Venous Cannula and IntroducerFeb 4, 2025
Manufacturer: MEDTRONIC MEXICO S DE R.L DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIOSYN™ Monofilament Absorbable SutureFeb 1, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FUSION COMPACT™ ENT NAVIGATION SYSTEMFeb 1, 2025
Manufacturer: MEDTRONIC NAVIGATION, INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
KANGHUI Implant SpineJan 30, 2025
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC StealthStation S7 Navigation SystemJan 24, 2025
Manufacturer: MEDTRONIC NAVIGATION INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Integrated Power Console (IPC) NTJan 24, 2025
Manufacturer: MEDTRONIC XOMED, INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC XPS StraightShot M4 MicrodebriderJan 24, 2025
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
AQUAMANTYS SealerJan 23, 2025
Manufacturer: NEXTPHASE MEDICAL DEVICES LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NEWPORT ™ Ventilator with AccessoriesJan 22, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NEWPORT ™ e360 Ventilator with Accessories, S ModelJan 22, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB ™ FT10 Electrosurgical GeneratorJan 17, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STREAMLINE Unipolar Temporary Myocardial Pacing LeadJan 14, 2025
Manufacturer: MEDTRONIC FABRICATION S.A.S.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PROTEGE RX Self-expanding Carotid Stent SystemJan 13, 2025
Manufacturer: MEDTRONIC INC. (PLYMOUTH)
Class: Kelas : 3
Risk Class: Kelas Resiko : D
X-PEDION Hydrophilic GuidewireJan 12, 2025
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB ™ FT10 Vessel Sealing GeneratorJan 12, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIRAGE ™ .008 Hydrophilic GuidewireJan 12, 2025
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SOFSILK ™ Wax or Silicone Coated Braided SilkJan 7, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
POLYSORB Braided Absorbable SutureJan 7, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Variloc Pelvic InstrumentJan 6, 2025
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
STEEL Monofilament Stainless SteelJan 6, 2025
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AVALUS Bioprothesis Model 400Jan 4, 2025
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC PSO Reusable InstrumentsJan 2, 2025
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC. SWINNEA ROAD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
AUTOLOGOUS IQ™Jan 2, 2025
Manufacturer: PLEXUS MANUFACTURING SDN,BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDO SHEARS ™ Auto Suture ™ ShearsDec 26, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIOSYN ™ Monofilament Absorbable SutureDec 26, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NOVAFIL Monofilament PolybutesterDec 26, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
POLYSORB ™ Braided Absorbable SutureDec 26, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SELECT SERIES Angled Tip Arterial CannulaDec 24, 2024
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SURGIPRO Monofilament PolypropyleneDec 22, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EEA AUTO SUTURE Circular Stapler with DST Series TechnologyDec 22, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIS Complete Monitoring SystemDec 19, 2024
Manufacturer: JABIL CIRCUIT SINGAPORE PTE LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DLP Straight Tip CannulaDec 15, 2024
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MINIMED RESERVOIRDec 12, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC ProbeDec 6, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MAXON Monofilament Absorbable SutureDec 4, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO GIA ™ Radial Reload with Tri-Staple TechnologyDec 4, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
GIA AUTO SUTURE Loading Unit with DST Series TechnologyDec 4, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PURITAN BENNETT ™ 840 Ventilator SystemNov 26, 2024
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NEWPORT ™ HT70 Plus VentilatorsNov 26, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CELESTICA Electroencephalograph ElectrodeNov 25, 2024
Manufacturer: CELESTICA ELECTRONICS (S) PTE., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PROTACK AUTO SUTURE Fixation Device 5mmNov 25, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Refill KitNov 23, 2024
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NELLCOR™ Bedside SpO2 Patient Monitoring SystemNov 23, 2024
Manufacturer: MEDIAN CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Nellcor™ SpO2 Module, Interface Cable IncludedNov 23, 2024
Manufacturer: JABIL CIRCUIT SINGAPORE PTE., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Nellcor™ Bedside Respiratory Patient Monitoring SystemNov 23, 2024
Manufacturer: COVIDIEN IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : B
RELIANT Button Switch Pencil HolsterNov 22, 2024
Manufacturer: NEW DEANTRONICS TAIWAN, LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ Rocker and Button Switch Pencil HolsterNov 22, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB Electrosurgical Return ElectrodesNov 22, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MAXON ™ Monofilament Absorbable SutureNov 21, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SPECIFY SURESCAN MRI 2X8 Lead KitNov 20, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
EEA ™ Auto Suture ™ Hemorrhoid and Prolapse Stapler with DST Series™ TechnologyNov 19, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EDGE ™ Rocker and Button Switch Pencil HolsterNov 19, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO CLIP™ III Auto Suture™ Clip Applier with Clip Logic™ Technology 5mmNov 18, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Catheter Access Port KitNov 18, 2024
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OCTOPUS NUVO Tissue StabilizerNov 17, 2024
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIAR Aortic Root CannulaNov 17, 2024
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB Bayonet ForcepsNov 14, 2024
Manufacturer: KIRWAN SURGICAL PRODUCTS LLC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COVIDIEN Pediatric SomaSensor®Nov 14, 2024
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN OxyAlert NIRSensorNov 12, 2024
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DLP Left Heart Vent CatheterNov 12, 2024
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC MYCARELINK SMART Patient ReaderNov 12, 2024
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MICRA™ VR2Nov 11, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MICRA™ AV2Nov 11, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC MRC Reusable InstrumentNov 5, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA., INC. SWINNEA ROAD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC SEXTANT II Reusable InstrumentOct 31, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
VECTRIS 1x8 Subcompat Trial LeadOct 30, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
WEM Microprocessed Electrosurgical Unit Model SS-501SXOct 30, 2024
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC TRIMLINE Reuseable InstrumentOct 29, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MAST QUADRANT Retractor SystemOct 29, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC. Swinnea Road
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BE-ST Pedicle Access NeedleOct 28, 2024
Manufacturer: LACEY MANUFACTURING CO., LLC. DBA BOSTON ENDO SURGICAL TECHNOLOGIES
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DAR Guedel AirwayOct 28, 2024
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
Evolut FX Loading SystemOct 18, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC CommunicatorOct 17, 2024
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ATTAIN Stability Quad MRI SureScan 4798Oct 16, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Lead End Cap KitOct 13, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Pin Plug KitOct 13, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO, VILLALBA.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
CAPSUREFIX NOVUSOct 10, 2024
Manufacturer: MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Dual Chamber Temporary External PacemakerOct 10, 2024
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
V-LOC™ 90 Absorbable Wound Closure DeviceOct 9, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI OMNAIL FEMORAL NAIL Instrument SetOct 9, 2024
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Patient ConnectorOct 9, 2024
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIRRO MRI DR SURESCAN DDME3D1Oct 4, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CAPSURE SENSE MRI SURESCAN LeadOct 2, 2024
Manufacturer: MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ENDURANT II Stent Graft SystemOct 2, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Adjustable SlitterOct 1, 2024
Manufacturer: MEDTRONIC, INC, MOUNDS VIEW.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
REVEAL LINQ Insertable Cardiac MonitorOct 1, 2024
Manufacturer: MEDTRONIC SINGAPORE OPERATIONS PTE., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NANOCROSS Elite 0.014Sep 30, 2024
Manufacturer: EV3 INC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROTEGE GPS Self-expanding Peripheral StentSep 30, 2024
Manufacturer: EV3, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TRAILBLAZER Support CatheterSep 30, 2024
Manufacturer: EV3 INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROTEGE™ GPS™ Self-expanding Peripheral Stent SystemSep 20, 2024
Manufacturer: MEDTRONIC INC. (PLYMOUTH)
Class: Kelas : 3
Risk Class: Kelas Resiko : D
REVEAL LINQ ™Sep 20, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CAPSTONE SPINAL SYSTEMSep 12, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Patient Programmer TH91DSep 10, 2024
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CAPSTONE PTC ™ SPINAL SYSTEMAug 30, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FLEXCATH ADVANCE ™Aug 28, 2024
Manufacturer: MEDTRONIC CRYOCATH LP.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB FT10 FT Series Energy PlatformAug 27, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY Lo-Contour Oral/Nasal Tracheal Tube Cuffed/ ReinforcedAug 27, 2024
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDO CLIP II AUTO SUTURE Clip Applier 10mm Medium/ LargeAug 21, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ACHIEVE ADVANCE Mapping CatheterAug 19, 2024
Manufacturer: LAKE REGION MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DxTERITY Diagnostic Angiography CatheterAug 19, 2024
Manufacturer: AVAILMED S.A. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PURITAN BENNETT 980 VentilatorAug 4, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Catheter Connecting CableAug 4, 2024
Manufacturer: CEA MEDICAL MANUFACTURING, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EXPORT ADVANCE Aspiration CatheterAug 1, 2024
Manufacturer: MEDTRONIC VASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MCGRATH MAC Video LaryngoscopeJul 31, 2024
Manufacturer: PLEXUS ELECTRONICA S, DE R.L. DE C.V.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
AURORA EV-ICD™ MRI SureScan™Jul 29, 2024
Manufacturer: MEDTRONIC EUROPE SARL
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Nitron CryoConsole™Jul 29, 2024
Manufacturer: COVIDIEN
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INVOS Adult rSO2 Sensor and AccessoriesJul 7, 2024
Manufacturer: CELESTICA ELECTRONICS (S) PTE LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CONTEGRA™ 200 Pulmonary Valved ConduitJul 5, 2024
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CLOSUREFAST Endovenous Radiofrequency Ablation (RFA) CatheterJul 2, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB FX8 FX Series Energy PlatformJun 25, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EEA Circular Stapler with Tri-Staple TechnologyJun 25, 2024
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
GAUTHIER Orthopedic Manual Surgical Instrument - 1Jun 19, 2024
Manufacturer: GAUTHIER BIOMEDICAL, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Tunneling ToolJun 19, 2024
Manufacturer: MEDTRONIC INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COVIDIEN Single Incision Laparoscopic Surgery (SILS)Jun 19, 2024
Manufacturer: CELESTICA DE MONTERREY S.A. DE C.V
Class: Kelas : 2
Risk Class: Kelas Resiko : B
GAUTHIER Orthopedic Manual Surgical Instrument - 2Jun 12, 2024
Manufacturer: GAUTHIER BIOMEDICAL, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Reusable Instrument & AccessoriesJun 7, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
CD HORIZON Spinal SystemJun 6, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CD Horizon Spinal System (Warsaw)Jun 3, 2024
Manufacturer: WARSAW ORTHOPEDIC INC, ALSO KNOWN AS : MEDTRONIC SOFAMOR DANEK MANUFACTURING
Class: Kelas : 2
Risk Class: Kelas Resiko : C
IN. PACT ADMIRAL Paclitaxel-coated PTA Balloon CatheterMay 6, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MICROMAR EasyDrill Cranial PerforatorApr 29, 2024
Manufacturer: MICROMAR INDUSTRIA E COMERCIO LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ABRE Venous Self-expanding Stent SystemApr 24, 2024
Manufacturer: MEDTRONIC INC
Class: Kelas : 3
Risk Class: Kelas Resiko : D
EVERA MRI S VR SureScanApr 22, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Manual Retraction KitApr 22, 2024
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PRIMO MRI™ VR SureScan™Apr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PRIMO MRI™ VR SureScan™Apr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MIRRO MRI DR SureScanApr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MIRRO MRI™ VR SureScan™Apr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PRIMO MRI™ DR SureScan™Apr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Mirro MRI VR SureScanApr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PRIMO MRI™ DR SureScan™Apr 7, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CAPSUREFIX NOVUSMar 29, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CAPSURE ™ EPIMar 29, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC CapSure Sense MRI SureScanMar 29, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MICRA Introducer Sheath with Hydrophilic CoatingMar 29, 2024
Manufacturer: TELEFLEX MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Attain Ability PlusMar 29, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Attain PerformaMar 29, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Reusable Instrument & Accessories (Warsaw)Mar 24, 2024
Manufacturer: WARSAW ORTHOPEDIC INC, ALSO KNOWN AS : MEDTRONIC SOFAMOR DANEK MANUFACTURING
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Patient ConnectorMar 19, 2024
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SPRINT QUATTRO SECUREMar 18, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SPRINT QUATTRO SECURE SMar 18, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ATTAIN ABILITYMar 18, 2024
Manufacturer: MEDTRONIC PUERTORICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Reusable Instrument & Accessories (Puerto Rico)Mar 18, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO, HUMACAO
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COVIDIEN NELLCOR Adult SpO2 SensorMar 16, 2024
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ATTAIN COMMAND ™ + SureValve ™ Guide Catheter for Left Heart DeliveryMar 13, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Solitaire ™ X Revascularization DeviceMar 7, 2024
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COMPIA MRI CRT-D SureScanMar 6, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ENDURANT ™ IIs Stent Graft SystemMar 6, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
REACT™ 71 CatheterMar 4, 2024
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDURANT™ II Stent Graft SystemMar 1, 2024
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Extension Accessory Kit (SCS)Feb 28, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Orthopedic Manual Surgical InstrumentFeb 27, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SOLARA ™ Quad CRT-P MRI SureScan ™Feb 21, 2024
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ACTIVE SCFeb 17, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ACTIVATE PCFeb 17, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DAR HME for Tracheostomized PatientsFeb 14, 2024
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DAR Electrostatic FilterFeb 12, 2024
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Micra MC1VR01 Transcatheter Pacing SystemFeb 6, 2024
Manufacturer: MEDTRONIC IRELAND.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC DBS Tunneling Tool Accessory KitFeb 6, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SPHERA SR MRI SureScanFeb 6, 2024
Manufacturer: MEDTRONIC SINGAPORE OPERATIONS PTE. LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AFFINITY AF 100 Arterial Filter with Balance BiosurfaceFeb 4, 2024
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ELEVISION HD 2 CCU Image and Video RECFeb 2, 2024
Manufacturer: SCHOLLY FIBEROPTIC, GMBH.,
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ADJUSTABLE Valve 6248VALFeb 1, 2024
Manufacturer: MEDTRONIC INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
AFFINITY NT OXYGENATOR WITH BALANCE BIOSURFACEFeb 1, 2024
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WRENCH Kit 5873WFeb 1, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLABA
Class: Kelas : 1
Risk Class: Kelas Resiko : A
AFFINITY NT Oxygenator with Balance Biosurface & Uncoated Cardiotomy/Venous ReservoirJan 31, 2024
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENT MR8™ Midas Rex Clearview™ ToolsJan 30, 2024
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC ENT MR8™ High-Speed Drill SystemJan 30, 2024
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TIPVISION VideoscopeJan 29, 2024
Manufacturer: SCHOLLY FIBEROPTIC, GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EleVision HD 2 CCU Image RECJan 27, 2024
Manufacturer: SCHOLLY FIBEROPTIC GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC STEALTHSTATION S8Jan 20, 2024
Manufacturer: MEDTRONIC NAVIGATION, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC DBS Extension Kit for Deep Brain StimulationJan 20, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTELLIS™ Neurostimulation for Chronic PainJan 20, 2024
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC DIVERGENCE Reusable InstrumentJan 5, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Hancock II Mitral ObturatorsJan 4, 2024
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENVEO R Delivery Catheter SystemDec 28, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MELODY Transcatheter Pulmonary ValveDec 28, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC AVALUS SizersDec 28, 2023
Manufacturer: MEDTRONIC HEART VALVES DIVISON.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC CryoConsole SystemDec 19, 2023
Manufacturer: MEDTRONIC CRYOCATH LP.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Fortrex™ HP PTA Balloon CatheterDec 19, 2023
Manufacturer: MEDTRONIC INC. (PLYMOUTH)
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VERTE STACK Spinal System CrescentDec 15, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.,HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DIVERGENCE Anterior Cervical Fusion SystemDec 14, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENVEO Pro Loading SystemDec 14, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLEARVIEW Intracoronary ShuntDec 13, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CARDIOBLATE Surgical Ablation PenDec 13, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIDAS REX MR8 Drill System AttachmentsDec 8, 2023
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
FREEZOR Xtra Cardiac Cryoablation CathetersDec 6, 2023
Manufacturer: MEDTRONIC CRYOCATH LP
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Patient Programmer MRI SureScanDec 4, 2023
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SYNCHROMED II Infusion PumpDec 4, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Coaxial Umbilical CableDec 4, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Autotransfusion Blood Collection Reservoir EL2120Nov 30, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Somanetics Invos OximeterNov 29, 2023
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Catheter PasserNov 28, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC OPEN PIVOT AP360 HEART VALVE AORTIC, Model 505DANov 28, 2023
Manufacturer: MEDTRONIC INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ASCENDA Intratechal Catheter 73 cm Pump Segment Revision KitNov 28, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PROFILE 3D™ Sizer Set 7680SNov 27, 2023
Manufacturer: MEDTRONIC HEART VALVES DIVISIONS
Class: Kelas : 1
Risk Class: Kelas Resiko : A
KANGHUI Omnail Femoral Nail KGD II Instrument SetNov 24, 2023
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ASCENDA Intrathecal Catheter with an 66 cm Spinal SegmentNov 24, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
LOSSNov 21, 2023
Manufacturer: MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VECTRIS SURESCAN MRI ( Subcompact Lead Kit for Spinal Cord Stimulation)Nov 18, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Special Holding Bag 1000mlNov 17, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN NELLCOR SpO2 SensorNov 15, 2023
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VALLEYLAB ™ Micro-Needle ElectrodesNov 14, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HANCOCK II T505Nov 14, 2023
Manufacturer: MEDTRONIC HEART VALVES
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INDERMIL® flexifuze™ Topical Tissue AdhesiveNov 14, 2023
Manufacturer: CONNEXICON MEDICAL LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SPECIFY SURESCAN MRI Lead KitsNov 14, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
VALLEYLAB™ ElectrodesNov 13, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY™ Endobronchial Tube/LeftNov 13, 2023
Manufacturer: MALLINCKRODT MEDICAL CORNAMADDY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VC2 Veneous CannulaNov 8, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BECKER External Drainage and Monitoring SystemNov 8, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Y-AdapterNov 8, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Suction and Anticoagulation AssemblyNov 8, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Autotransfusion Blood Collection ReservoirNov 8, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DUET External Drainage and And Monitoring System (EDMS)Nov 6, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Cardiotomy ReservoirNov 3, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
FREEZOR Cardiac Cryoablation CathetersOct 25, 2023
Manufacturer: MEDTRONIC CRYOCATH LP
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FREEZOR MAX Cardiac Cryoablation CathetersOct 25, 2023
Manufacturer: MEDTRONIC CRYOCATH LP
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MC2 Two Stage Veneous CannulaOct 25, 2023
Manufacturer: VIANT MEDICAL, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ARCTIC FRONT ADVANCE PROOct 25, 2023
Manufacturer: MEDTRONIC CRYOCATH LP
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AUTOLOG Wash KitOct 23, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EOPA CAP Arterial CannulaOct 20, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Single Stage Veneous Cannula with Right Angled TipOct 19, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Multiple Perfusion SetOct 19, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ARCTIC FRONT ADVANCE Cardiac CryoAblation CatheterOct 18, 2023
Manufacturer: MEDTRONIC CRYOCATH LP.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Waste Bag, Universal 10 LiterOct 17, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Cardiotomy Reservoir EL400Oct 17, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Catheter Connecting CableOct 17, 2023
Manufacturer: CEA GLOBAL DOMINICANA S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TRUCLEAR ™ Hysteroscope Set DuoOct 14, 2023
Manufacturer: HENKE-SASS WOLF, GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Open Pivot Heart Valve Sizer Set-576Oct 14, 2023
Manufacturer: MEDTRONIC INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DLP Pericardial SumpOct 9, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Coronary Ostial Perfusion CannulaOct 6, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INVOS™ PM7100 Patient MonitorOct 4, 2023
Manufacturer: ADVANTECH CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HELI-FX ENDOANCHOR SystemsOct 4, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SYMPLICITY SPYRAL Multi-electrode Renal Denervation CatheterSep 30, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SPRINTER LEGEND Rapid Exchange Balloon Dilatation CatheterSep 29, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TruClear Tissue Removal ShaverSep 26, 2023
Manufacturer: VIANT AS&O HOLDINGS, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
RESOLUTE ONYX Zotarolimus-Eluting Coronary Stent SystemSep 21, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RESOLUTE INTEGRITY Zotarolimus-Eluting Coronary Stent SystemSep 21, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
NC EUPHORA Rapid Exchange Balloon Dilatation CatheterSep 20, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SURGITIE™ AUTO SUTURE™ Ligating Loop with Delivery SystemSep 18, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EUPHORA Rapid Exchange Balloon Dilatation CatheterSep 15, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
THUNDER GuidewiresSep 12, 2023
Manufacturer: CEA GLOBAL DOMINICANA S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INTUITION Steerable Guidewire Hydro-TrackSep 12, 2023
Manufacturer: CEA GLOBAL DOMINICANA S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INTUITION Steerable Guidewire Pro/PelSep 12, 2023
Manufacturer: CEA GLOBAL DOMINICANA S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ONYX TruStar Zotarolimus-Eluting Coronary Stent SystemSep 7, 2023
Manufacturer: METRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
RADIANT Balloon Expandable Covered StentSep 7, 2023
Manufacturer: ATRIUM MEDICAL CORPORATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Midas Rex MR8 Drill System Surgical Dissecting ToolsSep 5, 2023
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SENTRANT Introducer Sheath with Hydrophilic CoatingSep 2, 2023
Manufacturer: TELEFLEX MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MIDAS REX Drill System HandpiecesAug 29, 2023
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TALENT Endoluminal Occluder SystemAug 28, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MIDAS Rex Curved BurAug 28, 2023
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDURANT IIs Stent Graft SystemAug 27, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Aortic PunchAug 25, 2023
Manufacturer: MEDTRONIC MEXICO S. DE. R. L. DE CV.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MIDAS REX MR8 Drill System HandpiecesAug 25, 2023
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
RELIANT Stent Graft Balloon CatheterAug 24, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIDAS REX MR8 Clearview Surgical Dissecting ToolsAug 23, 2023
Manufacturer: MEDTRONIC XOMED INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Cutter Driver for the HawkOne™ Directional Atherectomy SystemAug 21, 2023
Manufacturer: ATL TECHNOLOGY DG LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC HawkOne™ Directional Atherectomy SystemAug 15, 2023
Manufacturer: MEDTRONIC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEROCELAug 11, 2023
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ADMIRAL XTREME PTA Balloon CatheterAug 11, 2023
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE C.V
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NIM TRIVANTAGE EMG Endotracheal TubeAug 9, 2023
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
NIM FLEX EMG Endotracheal TubeAug 7, 2023
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
KANGHUI General Spine System (CoCr Rod)Aug 4, 2023
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VISI-PRO Balloon-Expandable Peripheral Stent SystemAug 1, 2023
Manufacturer: EV3, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ENDO-SCRUB® 2 SHEATHJul 26, 2023
Manufacturer: MEDTRONIC XOMED INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Parietene DS Composite MeshJul 20, 2023
Manufacturer: SOFRADIM PRODUCTION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC WIRELESS EXTERNAL NEUROSTIMULATORJul 12, 2023
Manufacturer: PLEXUS MANUFACTURING SDN. BHD
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CALIMA BLOWER 220-240VJul 7, 2023
Manufacturer: VINCENT MEDICAL (DONGGUAN) TECHNOLOGY CO. LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
RESOLUTE ONYX Zotralimus-Eluting Coronary Stent SystemJul 4, 2023
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
PROGRIP Self-Gripping Polyester MeshJun 25, 2023
Manufacturer: SOFRADIM PRODUCTION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC ControllerJun 23, 2023
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC UNIVERSAL II Slitter 6230UNIJun 19, 2023
Manufacturer: MEDTRONIC INC, MOUNDS VIEW.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
AZURE XT DR MRI SureScanJun 8, 2023
Manufacturer: MEDTRONIC SINGAPORE OPERATIONS PTE.LTD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SENSIGHT Directional Lead Kit B33005Jun 7, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Select 3D II Arterial CannulaMay 29, 2023
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROGRIP Self-Gripping Polypropylene MeshMay 19, 2023
Manufacturer: SOFRADIM PRODUCTION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY™ Pediatric Tracheostomy Tube CufflessMay 17, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIGASURE Maryland Jaw Laparoscopic Sealer/DividersMay 16, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE Blunt Tip Sealer/Divider, Nano-coatedMay 12, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HAZEMay 10, 2023
Manufacturer: CELSIUS MEDICAL, S.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PARIETENE Flat Sheet Mesh and Lightweight MeshApr 19, 2023
Manufacturer: SOFRADIM PRODUCTION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ECO Posterior Thoracolumbar Fixation SystemApr 19, 2023
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI ECO MIS Minimally Invasive Posterior Thoracolumbar ImplantApr 19, 2023
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY Nasopharyngeal AirwayApr 18, 2023
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PARIETEX™ Hydrophilic MeshApr 6, 2023
Manufacturer: SOFRADIM PRODUCTION
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MYCARELINK Patient MonitorApr 6, 2023
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ARCTIC FRONT ADVANCE PROApr 3, 2023
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MYCARELINK Patient MonitorMar 27, 2023
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CARELINK SMARTSYNC Device Manager BaseMar 22, 2023
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI ECO MIS Minimally Invasive Spine System Instrument Standard Set-Whole SetMar 8, 2023
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Brockenbrough Curved NeedleMar 6, 2023
Manufacturer: MEDTRONIC MEXICO S. DE R.L DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-MEDICUS™ Adult Venous Cannula KitsFeb 8, 2023
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
StraighShot Handpiece AccessoriesFeb 7, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC ENT BursFeb 2, 2023
Manufacturer: COVIDIEN
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SLIDE-ON ENDOSHEATH SYSTEMFeb 2, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENT CHANNELED SHEATH SLIDE-ON ENDOSHEATH SystemFeb 1, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TNE-D ENDOSHEATH SYSTEM FOR THE TNE-2000D ESOPHAGOSCOPEJan 31, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Shiley ™ Oral/Nasal Endotracheal Tube Intermediate Cuff Non DEHPJan 25, 2023
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SKEETER Oto-Flex BursJan 25, 2023
Manufacturer: COVIDIEN
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC ScholarshipJan 25, 2023
Manufacturer: COVIDIEN
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COVIDIEN Sinus Secretion CollectorJan 25, 2023
Manufacturer: COVIDIEN
Class: Kelas : 1
Risk Class: Kelas Resiko : A
TIMESH SystemJan 25, 2023
Manufacturer: MEDTRONIC NEUROSURGERY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN 4K/UHD LaparoscopeDec 30, 2022
Manufacturer: HENKE-SASS, WOLF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PATIENT PROGRAMMER TH90DDec 29, 2022
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SENSIGHT™ Depth Stop and Cranial Tunneler KitDec 29, 2022
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SENSIGHT™ Extension KitDec 21, 2022
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
COVIDIEN 4K/UHD ArthroscopeDec 19, 2022
Manufacturer: HENKE-SASS, WOLF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC EVOLUT Pro Plus SystemDec 12, 2022
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI CORMATE ImplantDec 5, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INSPIRED Ventilation Breathing CircuitDec 5, 2022
Manufacturer: VINCENT MEDICAL (DONG GUANG) MANUFACTURING CO.,LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EVOLUT™ PRO + Delivery Catheter SystemNov 30, 2022
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TIMESH SystemNov 22, 2022
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HYSTEROLUX Fluid Management SystemNov 18, 2022
Manufacturer: W.O.M. WORLD OF MEDICINE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EVOLUT Pro + Loading SystemNov 16, 2022
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Eco Deformity InstrumentNov 14, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SENSIGHT Extension Tunneler KitOct 31, 2022
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SENSIGHT Burr Hole DeviceOct 27, 2022
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AMPHIRION™ Deep PTA CatheterOct 27, 2022
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EXPORT™ APOct 25, 2022
Manufacturer: MEDTRONIC VASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI CAPMATE ImplantOct 20, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Carelink ProgrammerOct 20, 2022
Manufacturer: MEDTRONIC INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SONICISION™ 7 Curved Jaw Cordless Ultrasonic DissectionOct 14, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI CAPMATE Peek Cage InstrumentOct 14, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
Stealth Autoguide SystemOct 4, 2022
Manufacturer: MEDTRONIC NAVIGATION, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-PROBE Disposable Insert DP38 AdultSep 30, 2022
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EXPORT ADVANCE™ Aspiration CatheterSep 27, 2022
Manufacturer: MEDTRONIC VASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Implant -TraumaSep 18, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ Telescoping Smoke Evacuation Rocker Switch Pencil Edge™ Blade ElectrodeSep 2, 2022
Manufacturer: NEW DEANTRONICS TAIWAN LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ADMIRAL™ XTREME PTA CatheterAug 29, 2022
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN PTFE Polymer Pledgets Nonabsorbable Pre-punched PledgetsAug 11, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Titanium Implant interlocking NailAug 11, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SOLITAIRE AB Neurovascular Remodeling DeviceAug 4, 2022
Manufacturer: MICRO THERAPEUTICS, INC, D/B/A EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI Trauma Screw LargeAug 3, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MCGRATH X BLADE X3 Disposable Laryngoscope BladeAug 1, 2022
Manufacturer: MEDICONCEPTS TECHNOLOGY (SHENZHEN) COMPANY LIMITED
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PERCEPT PC BrainSenseJul 22, 2022
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MCGRATH MAC Disposable Laryngoscope BladeJun 23, 2022
Manufacturer: VITALTEC CORPORATION
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MINIMED™ Silhouette Infusion Set, SC1Jun 17, 2022
Manufacturer: UNOMEDICAL DEVICES SA. OF C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MINIMED™ Mio Infusion Set, SC1Jun 17, 2022
Manufacturer: UNOMEDICAL DEVICES SA. OF C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MINIMED™ Quick Set Infusion Set, SC1Jun 14, 2022
Manufacturer: UNOMEDICAL DEVICES SA. OF C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BIO-MEDICUS Life Support Arterial Catheter (LS96010)Jun 11, 2022
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BL250 Kit 025 CVVH/CVVHDJun 7, 2022
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MINIMED™ Sure T Infusion Set, SC1Jun 5, 2022
Manufacturer: UNOMEDICAL DEVICES SA. OF C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CARPEDIEM BL250 Kit 0075 CVVHJun 4, 2022
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PIPELINE Flex Embolization Device with Shield TechnologyJun 1, 2022
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BL250 Kit 015 CVVH/CVVHDMay 28, 2022
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORTREX 0.035" OTW PTA Balloon CatheterMay 28, 2022
Manufacturer: COVIDIEN LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
REBAR -27 Micro CatheterMay 26, 2022
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
RAPIDCROSS™ PTA Rapid Exchange Balloon Dilatation CatheterMay 26, 2022
Manufacturer: EV3, Inc.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HYPERGLIDE Occlusion Balloon SystemMay 25, 2022
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-MEDICUS Life Support CatheterMay 24, 2022
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CAPNOSTREAM 35 Portable Respiratory MonitorMay 23, 2022
Manufacturer: SANMINA HUNTSVILLE
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MARKSMAN CatheterMay 22, 2022
Manufacturer: MEDTRONIC MEXICO S, DE R.L DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Single Chamber Temporary External Pacemaker 53401May 20, 2022
Manufacturer: PLEXUS MANUFACTURING SDN., BHD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TruClear Operative HysteroscopesMay 19, 2022
Manufacturer: HENKE-SASS WOLF, GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
W.O.M. Laparoscopy Pump (LAP-Pump) and AccessoriesMay 16, 2022
Manufacturer: W.O.M. WORLD OF MEDICINE GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TRUCLEAR Elite HysteroscopesMay 12, 2022
Manufacturer: HENKE-SASS WOLF, GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DLP Pediatric One Piece Arterial CannulaeMay 10, 2022
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Insufflator 50L and AccessoriesMay 10, 2022
Manufacturer: W.O.M. WORLD OF MEDICINE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TRUCLEAR Hysteroscopic Tissue Removal SystemMay 9, 2022
Manufacturer: NPA DE MEXICO S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VENASEAL Closure SystemApr 27, 2022
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INVOS PM7100 Patient Monitor and AccessoriesApr 27, 2022
Manufacturer: AVNET GLOBAL SOLUTION CENTER.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIGASURE Retractable L-Hook Laparoscopic Sealer/DividerApr 27, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MVP Micro Vascular Plug SystemApr 27, 2022
Manufacturer: COVIDIEN
Class: Kelas : 3
Risk Class: Kelas Resiko : D
VERSAONE™ Fascial Closure System Blades Trocar with Fixation Cannula 12mm StandardApr 26, 2022
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SONICISION Curved Jaw Cordless Ultrasonic DissectorApr 25, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SIGNIA™ Loading Units with Tri-Staple™ 2.0 CartridgesApr 23, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ REM Adult Universal Patient Return ElectrodeApr 23, 2022
Manufacturer: COVIDIEN DEUTSCHLAND GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider 12 mm - 12 cmApr 23, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ARGON ElectrodeApr 23, 2022
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NELLCOR Portable SpO2 Patient Monitoring SystemApr 21, 2022
Manufacturer: MEDIAN CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DAR Infant Breathing CircuitApr 21, 2022
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SURGINEEDLE™ Auto Suture™ Insufflation NeedleApr 20, 2022
Manufacturer: CELESTICA DE MONTERREY S.A DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VALLEYLAB™ Smoke Evacuation PencilApr 20, 2022
Manufacturer: MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE Exact Dissector, Nano-coated, 20.6 mm - 21 cmApr 20, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy EyeApr 19, 2022
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SURGISLEEVE Wound ProtectorApr 19, 2022
Manufacturer: NPA DE MEXICO S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TRI-STAPLE™ 2.0 and Reinforced 2.0 ReloadsApr 13, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO GIA™ Curved Tip Reload with Tri-Staple™ TechnologyApr 11, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO DISSECT AUTO SUTURE Dissector 5mmApr 9, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Otoskop (Otoscope)Apr 5, 2022
Manufacturer: HENKE-SASS, WOLF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COREVALVE™ EVOLUT™ R Transcatheter Aortic ValveApr 2, 2022
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
COREVALVE™ EVOLUT™ PRO Transcatheter Aortic ValveApr 2, 2022
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INSPIRED™ Auto-feed Humidification ChamberMar 30, 2022
Manufacturer: VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Nasoskop (Sinuscope)Mar 30, 2022
Manufacturer: HENKE-SASS, WOLF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MICROSTREAM™ Advance Filter LinesMar 23, 2022
Manufacturer: QUASAR MEDICAL (THAILAND) CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MICROSTREAM™ Advance Filter and Luer Sampling LinesMar 22, 2022
Manufacturer: QUASAR MEDICAL (THAILAND) CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HISERN Disposable Anesthesia MaskMar 16, 2022
Manufacturer: ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
AMPLATZ Goose Neck Snare and KitMar 15, 2022
Manufacturer: EV3 INC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Zystoskop (Cystoscope)Mar 9, 2022
Manufacturer: HENKE-SASS, WOLF GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HISERN Disposable Anesthesia Breathing CircuitMar 9, 2022
Manufacturer: ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PHENOM™ CathetersMar 9, 2022
Manufacturer: MEDTRONIC MEXICO S DE R L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AMPLATZ GOOSE NECK Microsnare and KitMar 7, 2022
Manufacturer: EV3 INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INSPIRED Ventilator HumidifierFeb 23, 2022
Manufacturer: VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PURITAN BENNETT 980 Universal VentilatorFeb 7, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PURITAN BENNETT 980 Universal Ventilator Pendant Configuration VentilatorFeb 4, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PURITAN BENNETT 980 VentilatorFeb 4, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ REM POLYHESIVE™ Patient Return ElectrodeJan 31, 2022
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CROME™ VR MRI SureScan™Jan 24, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CROME™ VR MRI SureScan™Jan 24, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CROME™ DR MRI SureScan™Jan 24, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI Titanium Implant Screw SpineJan 20, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Titanium Implant ScrewJan 20, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CROME™ HF CRT-D MRI SureScan™Jan 18, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CROME™ DR MRI SureScan™Jan 18, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CROME™ HF Quad CRT-D MRI SureScan™Jan 18, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CROME™ HF CRT-D MRI SureScan™Jan 18, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CROME™ HF Quad CRT-D MRI SureScan™Jan 14, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI Trauma Screw Small MiniJan 13, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI NEOGENJan 10, 2022
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INSPIRED Heated Breathing CircuitJan 10, 2022
Manufacturer: VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COBALT™ XT DR MRI SureScan™Jan 8, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
COBALT™ DR MRI SureScan™Jan 8, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
COBALT™ HF CRT-D MRI SureScan™Jan 8, 2022
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI ECO ImplantDec 31, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COBALT™ XT HF Quad CRT-D MRI SureScan™Dec 29, 2021
Manufacturer: MEDTRONIC EUROPE S.A.R.L
Class: Kelas : 3
Risk Class: Kelas Resiko : D
INTELLIS™ AdaptiveStimDec 29, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI ECO Orthopedic InstrumentDec 21, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SHILEY™ Endobronchial Tube Left with Carinal HookDec 20, 2021
Manufacturer: COVIDIEN FORMERLY MALLINCKRODT MEDICAL CORNAMADDY
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BL250 Pre-assembled Device for Neonatal and Pediatric Hemofiltration/HemodialysisDec 14, 2021
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Bone ScrewsDec 14, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VARILOC Bone PlatesDec 10, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ARCTIC FRONT ADVANCE™ Cardiac CryoAblation CatheterDec 7, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Pipeline™ Vantage Embolization Device with Shield Technology™Dec 2, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CARPEDIEMNov 30, 2021
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC StealthStation FlexENT™Nov 18, 2021
Manufacturer: MEDTRONIC NAVIGATION, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EPISTAT Nasal CatheterNov 5, 2021
Manufacturer: COVIDIEN
Class: Kelas : 1
Risk Class: Kelas Resiko : A
TICRON™ Coated and Uncoated Braided PolyesterNov 2, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Shiley™ Pediatric Tracheostomy Tube with TaperGuard™ CuffOct 19, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SELECTSECURE MRI SureScanOct 13, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI Topfix InstrumentSep 25, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MyCareLink Patient MonitorSep 20, 2021
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ACTIVE RCSep 16, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO JUNCOS.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SURGIPRO II Monofilament PolypropyleneSep 15, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KANGHUI Single-seater ToolSep 15, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
FLEXCATH ADVANCE™Sep 1, 2021
Manufacturer: MEDTRONIC CRYOCATH LP
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CRESCENT Spinal SystemAug 31, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SELECTSITE™ C304-HIS Deflectable Catheter SystemAug 24, 2021
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
STRATA II Adjusment KitAug 21, 2021
Manufacturer: PMC, LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Restore Ultra SureScanAug 17, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
KABLP05 - KIT PEX X AMPLYAAug 14, 2021
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
KABL14P05 - KIT CPFA X AMPLYAAug 11, 2021
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MAXON and MAXON CV Monofilament Absorbable SutureAug 7, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Axium™ Prime Detachable Coil SystemJul 30, 2021
Manufacturer: MEDTRONIC MEXICO S. DE R. L. DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Epicardial PatchJul 29, 2021
Manufacturer: MEDTRONIC INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Percutaneous Lead IntroducerJul 28, 2021
Manufacturer: GREATBATCH MEDICAL, S. DE R.L. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MICROSTREAM Advance Filter and Luer Sampling LinesJul 26, 2021
Manufacturer: QUASAR ELECTRONICS TECHNOLOGY (DONGGUAN) CO., LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FLEXON Multifilament Temporary Cardiac Pacing LeadJul 24, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LAUNCHER Guiding CatheterJul 15, 2021
Manufacturer: MEDTRONIC MEXICO S.DE R. L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SOFSILK Wax Coated and SOFSILK Silicon Coated Braided SilkJul 15, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CONCERTO™ Detachable Coil System (PGLA)Jul 9, 2021
Manufacturer: MEDTRONIC MEXICO S. DE. R. L, DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BELLCO Drainage BagJul 7, 2021
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HANCOCK II Aortic ObturatorsJul 4, 2021
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 1
Risk Class: Kelas Resiko : A
AXIUM™ Detachable Coil System (PGLA)Jul 1, 2021
Manufacturer: MEDTRONIC MEXICO S. DE R. L. DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AZURE™ XT DR MRI SureScan™Jul 1, 2021
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
VIVA CRT - PJul 1, 2021
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
NEO SUPRA Intramedullary NailsJun 25, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC External Drainage and Monitoring CathetersJun 24, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
GIA Stapler with Tri-Staple TechnologyJun 21, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIDAS REX MR8 Clearview Surgical Dissecting ToolsJun 15, 2021
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INNERVISIONJun 15, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC External Drainage and Monitoring CatheterJun 15, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AXIUM™ Detachable Coil SystemJun 11, 2021
Manufacturer: MEDTRONIC MEXICO S. DE R. L. DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AXIUM™ Detachable Coil System (Nylon)Jun 11, 2021
Manufacturer: MEDTRONIC MEXICO S. DE R. L. DE CV
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC ElectrodeJun 10, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CONTEGRA 200 Pulmonary Valved Conduit (Unsupported)May 20, 2021
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
BL640 KIT HFR 17 (HFR Evolution Therapy)May 5, 2021
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CRAGG-MCNAMARA™ 5F Valved Infusion CatheterMay 5, 2021
Manufacturer: COVIDIEN FORMERLY MALLINCRODT MEDICAL CORMANADDY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Valleylab™ Laparoscopic Smoke Evacuation System Active, PassiveMay 5, 2021
Manufacturer: CONSOLIDATED MEDICAL EQUIPMENT COMPANY (CONMED)
Class: Kelas : 2
Risk Class: Kelas Resiko : B
KANGHUI InstrumentMay 5, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
KANGHUI Instrument TraumaMay 5, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
KANGHUI Titanium Implant Plate SpineMay 5, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EMPRINT™ Ablation Generator with THERMOSPHERE™ TechnologyMay 1, 2021
Manufacturer: EMBLATION LIMITED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLEARIFY™ Visualization SystemMay 1, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VALLEYLAB™ Smoke AttachmentMay 1, 2021
Manufacturer: NEW DEANTRONICS TAIWAN LTD
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CRAGG-MCNAMARA™ 4F Valved Infusion CatheterMay 1, 2021
Manufacturer: COVIDIEN FORMERLY MALLINCRODT MEDICAL CORMANADDY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PREVAIL™ Paclitaxel-coated PTCA Balloon CatheterApr 22, 2021
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TRI-AD 2.0 Adam Band Sizer SetApr 21, 2021
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 1
Risk Class: Kelas Resiko : A
BL640 KIT SUPRA 17Apr 20, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BL640 KIT SUPRA 13Apr 20, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BL640 KIT HFR AEQ – HFR17Apr 20, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ATTAIN Venogram Balloon CatheterApr 19, 2021
Manufacturer: B.BRAUN MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CARELINK ENCORE ProgrammerApr 19, 2021
Manufacturer: PLEXUS MANUFACTURING SDN., BHD.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SAFESHEATH II Introducer SystemApr 16, 2021
Manufacturer: OSCOR INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CONFIDA Brecker GuidewireApr 13, 2021
Manufacturer: EPFLEX FEINWERKTECHNIK GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ Disposable Electrosurgical PencilsApr 9, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Trialing and Intraoperative Screening CableApr 9, 2021
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN NELLCOR Forehead SpO2 SensorApr 7, 2021
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CONCERTO™ Detachable Coil System – PGLA FiberApr 7, 2021
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ABL14P05 - Pre-assembled device for CPFA for AmplyaApr 6, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ABLP05 - Pre-assembled device for PEX for AmplyaApr 6, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC NERVE Monitoring SystemMar 30, 2021
Manufacturer: MEDTRONIC XOMED INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
HBIOFLUIDS Haemofiltration and Dialysis SolutionMar 30, 2021
Manufacturer: HAEMOPHARM BIOFLUIDS S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
HBIOFLUIDS Sodium Citrate SolutionMar 30, 2021
Manufacturer: HAEMOPHARM BIOFLUIDS S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BELLCO Pre-assembled device for RRT for AmplyaMar 30, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE Dolphin TipMar 30, 2021
Manufacturer: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ABLE - Pre-assembled device for HP for AmplyaMar 30, 2021
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TICRON Coated and Uncoated Braided PolyesterMar 25, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AXIUM Detachable Coil SystemMar 25, 2021
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SHILEY Hi-Lo Hand Pressure GaugeMar 25, 2021
Manufacturer: VBM MEDIZINTECHNIK GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DERMALON Monofilament NylonMar 23, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE ATLAS™ Tissue FusionMar 23, 2021
Manufacturer: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
Midas Rex Legend Depth Stop AttachmentsMar 23, 2021
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VENASEAL Closure SystemMar 20, 2021
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ONYX Liquid Embolic SystemMar 20, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AXIUM™ Prime Detachable Coil SystemMar 20, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC NIM TRIVANTAGE™ EMG Endotracheal TubeMar 19, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
KANGHUI Titanium Implant PlateMar 19, 2021
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE Curved, Small Jaw, Open Sealer/Divider 16.5 mm - 19 cmMar 17, 2021
Manufacturer: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN NELLCOR Pediatric SpO2 Sensor ClipMar 17, 2021
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY Endobronchial Tube / LeftMar 17, 2021
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
WEM Bipolar ForcepsMar 17, 2021
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN NELLCOR Pediatric SpO2 SensorMar 17, 2021
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY™ Oral/Nasal Tracheal Tube Cuffless, Murphy EyeMar 17, 2021
Manufacturer: KENDALL-GAMMATRON CO., LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MONOSOF Monofilament NylonMar 13, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Neonatal SpO2 SensorMar 13, 2021
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
GIA Auto Suture Stapler with DST Series TechnologyMar 13, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SURGIPRO II Monofilament PolypropyleneMar 9, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY™ Oral RAE Tracheal Tube Cuffless / Murphy EyeMar 6, 2021
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COOL-TIP RF Ablation Cluster Electrode Kit E SeriesMar 6, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COOL-TIP RF Ablation System E SeriesMar 6, 2021
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CRAGG-MCNAMARA™ 4F Valved Infusion CatheterMar 6, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CRAGG-MCNAMARA™ 5F Valved Infusion CatheterMar 6, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY Speaking ValveMar 6, 2021
Manufacturer: COVIDIEN FORMERLY MALLINCKRODT DAR S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIGASURE™ Curved Jaw, Open Sealer/DividerMar 6, 2021
Manufacturer: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING, LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COOL-TIP RF Ablation High Power Patient Return Electrode E SeriesMar 6, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY Esophageal Tracheal Airway with X-Ray LineMar 6, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY Tracheostomy Tube Cuffless with Inner CannulaMar 4, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY Neonatal Tracheostomy Tube CufflessMar 4, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MONOSOF Monofilament NylonMar 3, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CELLO Balloon Guide Catheter, Intravascular Catheter with CuffMar 3, 2021
Manufacturer: FUJI SYSTEMS CORPORATION SHIRAKAWA PLANT
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ECHELON™ -10 Micro CatheterMar 3, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN PTFE Polymer Pledgets Nonabsorbable Pre-punched PledgetsMar 3, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Chromic Gut Absorbable SutureMar 3, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PIPELINE Flex Embolization DeviceMar 3, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
VASCUFIL Coated Monofilament PolybutesterMar 3, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AXIUM Prime Detachable Coil SystemMar 3, 2021
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 3
Risk Class: Kelas Resiko : D
WEM Monopolar ForcepsFeb 25, 2021
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COOL-TIP RF Ablation Remote Temperature Probe E SeriesFeb 25, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
NAVIEN Intracranial Support CatheterFeb 25, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN InsufflatorFeb 25, 2021
Manufacturer: W.O.M. WORLD OF MEDICINE GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
WEM Electrosurgical ElectrodeFeb 25, 2021
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLEANCOAT™ Laparoscopic Curved Spatula Electrode CoatedFeb 25, 2021
Manufacturer: NEW DEANTRONICS TAIWAN, LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FLEXON Multifilament Temporary Cardiac Pacing LeadFeb 25, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN InsufflatorFeb 25, 2021
Manufacturer: W.O.M. WORLD OF MEDICINE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY™ Oral/Nasal Tracheal Tube Cuffless / ReinforcedFeb 25, 2021
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COOL-TIP RF Ablation Multiple Electrode Kit E SeriesFeb 18, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SIGNIA ForkliftFeb 18, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
REBAR -18 Micro CatheterFeb 16, 2021
Manufacturer: MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ECHELON™ -14 Micro CatheterFeb 16, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Electrosurgery Reusable Hand Instruments and AccessoriesFeb 15, 2021
Manufacturer: ACKERMANN INSTRUMENTE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Reusable ObturatorFeb 11, 2021
Manufacturer: ACKERMANN INSTRUMENTE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MARATHON Flow Directed Micro CatheterFeb 11, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SURGIPRO™ II Monofilament PolypropyleneFeb 10, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AVIGO Hydrophilic GuidewireFeb 10, 2021
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ARGYLE™ Safety Fistula Cannula with Anti-Reflux ValveFeb 9, 2021
Manufacturer: NIPPON COVIDIEN LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COOL-TIP RF Ablation Single Electrode Kit E SeriesFeb 9, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLOSURERFG Radiofrequency GeneratorFeb 9, 2021
Manufacturer: PLEXUS CORP.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WEM Multifunctional Electrosurgical HandpieceFeb 9, 2021
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
V-LOC™ PBT Non-absorbable ReloadFeb 8, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™Laparoscopic Electrode, SolidFeb 8, 2021
Manufacturer: NEW DEANTRONICS TAIWAN, LTD.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
WEM Disposable Catheter for ElectrosurgeryFeb 8, 2021
Manufacturer: WEM ELECTRONIC EQUIPMENT LTDA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Suction IrrigationFeb 8, 2021
Manufacturer: ACKERMANN INSTRUMENTE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ETH-Needle HolderFeb 4, 2021
Manufacturer: ACKERMANN INSTRUMENTE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VALLEYLAB Fine Needle ElectrodeFeb 3, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ Micro-Needle ElectrodeFeb 3, 2021
Manufacturer: VENUSA DE MEXICO S.A. DE C.V
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLOSURERFS Endovenous Radiofrequency StyletFeb 3, 2021
Manufacturer: PRECISION CONCEPTS COSTA RICA S.A. (A.K.A PCMT)
Class: Kelas : 2
Risk Class: Kelas Resiko : C
COVIDIEN Electrosurgery Instruments and AccessoriesFeb 1, 2021
Manufacturer: ACKERMANN INSTRUMENTE GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALLEYLAB™ Ball ElectrodesFeb 1, 2021
Manufacturer: BOVIE MEDICAL CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO MINI-SHEARS™ Auto Suture™ ShearsFeb 1, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TA™ Auto Suture™ Loading Unit with DST Series™ TechnologyJan 29, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EDGE Electrosurgical PencilsJan 28, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SURGIWAND™ II AUTO SUTURE™ Suction and Irrigation DeviceJan 28, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDO DISSECT™ AUTO SUTURE™ Dissector with Roticulator™ Technology 5mmJan 25, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SILS™ Port Flexible PortJan 25, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDO CLIP™ Autosuture Clip ApplierJan 24, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PARAMOUNT Mini GPS Balloon – Expandable Biliary Stent SystemJan 22, 2021
Manufacturer: EV3, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO DISSECT™ Auto Suture™ Dissector 5mmJan 20, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DAR Adult Breathing CircuitJan 19, 2021
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC SOLO-TRAK-KR Percutaneous Lead Introducer (PLI)Jan 15, 2021
Manufacturer: MEDTRONIC INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Adult SomaSensor®Jan 7, 2021
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
COVIDIEN Trocar With Silicon Valve, DismountableJan 1, 2021
Manufacturer: ACKERMANN INSTRUMENTE GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
KENDALL Sterile Water for Inhalation USP with O2 Humidifier Adapter, 325 mlJan 1, 2021
Manufacturer: COVIDIEN DEUTSCHLAND MANUFACTURING GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENLITE Glucose SensorJan 1, 2021
Manufacturer: MEDTRONIC MINIMED.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DAR Catheter MountJan 1, 2021
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
ENDO CLOSE™ AUTO SUTURE™ Trocar Site Closure DeviceJan 1, 2021
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Paradigm Insulin PumpDec 30, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VALLEYLAB™ Tungsten Loop ElectrodesDec 30, 2020
Manufacturer: BOVIE MEDICAL CORPORATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
V-LOC 180 Absorbable Wound Closure DeviceDec 29, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EVERCROSS™ .035" OTW PTA Dilatation CatheterDec 29, 2020
Manufacturer: EV3 INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VERSAONE™ Bladeless SwapDec 26, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY Endobronchial Tube / RightDec 22, 2020
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
LIGASURE IMPACT™ Curved, Large Jaw, Open Sealer/Divider 36 mm - 18 cmDec 22, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENDO CLIP™ AUTO SUTURE™ Clip ApplyDec 22, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY Adult Flexible Tracheostomy Tube with Taperguard Cuff, Reusable Inner CannulaDec 22, 2020
Manufacturer: COVIDIEN FORMERLY MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY™ Endobronchial Tube / Left with Carinal HookDec 22, 2020
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VERSAONE™ Bladed TrocarDec 18, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
McGRATH MAC Video LaryngoscopeDec 18, 2020
Manufacturer: AIRCRAFT MEDICAL LIMITED.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
COVIDIEN WarmTouch BlanketsDec 18, 2020
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
FORCE TRIAD Energy Platform and AccessoriesDec 18, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PALINDROME Precision HSI Chronic Catheter and KitsDec 18, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE™ Maryland Jaw Sealer/DividerDec 17, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AMPLYADec 17, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PALINDROME SI Chronic Catheter and KitsDec 17, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PALINDROME H Chronic Catheter and KitsDec 17, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PALINDROME HSI Chronic Catheter and KitsDec 16, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MAHURKAR Elite Acute Triple Lumen Catheter and KitsDec 16, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PALINDROME Precision H Chronic Catheter and KitsDec 16, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Paradigm Insulin Pump-MMT-515Dec 15, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PALINDROME Chronic Catheter and KitsDec 8, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY™ Oral/Nasal Tracheal Tube Cuffed / Reinforced with StyletDec 7, 2020
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SELECTSECURE MRI SureScanDec 7, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
KANGHUI Instrument SpineDec 7, 2020
Manufacturer: CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Paradigm Insulin Pump-MMT-715Dec 7, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DAR Adult-Pediatric Electrostatic Filter HMEDec 7, 2020
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY™ Tracheostomy Tube Cuffless with Inner CannulaDec 7, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-MEDICUS Venous Insertion KitDec 4, 2020
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE CV.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY TaperGuard Evac Oral Tracheal TubeDec 3, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CONTOUR 3D Sizer Set 7690SDec 3, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
DAR Pediatric-Neonatal Closed Suction SystemDec 3, 2020
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
PALINDROME Precision SI Chronic Catheter and KitsDec 2, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC VALVE HANDLEDec 2, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISON.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Valve HandleDec 2, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 1
Risk Class: Kelas Resiko : A
INTRASTENT™ LD MEGA™ Large Diameter Peripheral StentDec 1, 2020
Manufacturer: EV3, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PARADIGM Insulin Pump-MMT 522Dec 1, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDO CLINCH™ II AUTO SUTURE™ Grasper 5mmDec 1, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : B
TRI-AD 2.0 Adams Tricuspid BandNov 29, 2020
Manufacturer: MEDTRONIC MEXICO S DE R.L DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AZURE XT SR MRI SureScanNov 29, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MAHURKAR Elite Acute Dual Catheter and KitsNov 26, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SHILEY™ Oral RAE Tracheal Tube Cuffed / Murphy EyeNov 26, 2020
Manufacturer: MALLINCKRODT MEDICAL
Class: Kelas : 2
Risk Class: Kelas Resiko : B
AZURE™ S SR MRI SureScan™Nov 26, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
SHILEY™ Hi-Contour Oral/Nasal Tracheal Tube Cuffed Murphy EyeNov 26, 2020
Manufacturer: COVIDIEN LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEROCEL Nasal DressingNov 26, 2020
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SURE-T ParadigmNov 25, 2020
Manufacturer: UNOMEDICAL DEVICES S.A. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Indigo HighSpeed Otologic DrillNov 24, 2020
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DAR Closed Suction SystemNov 23, 2020
Manufacturer: MALLINCKRODT DAR S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Annuloplasty HandleNov 22, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Annuloplasty HandleNov 22, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 1
Risk Class: Kelas Resiko : A
SONICISION Battery Powered DevicesNov 19, 2020
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PRIMEADVANCED Surescan MRINov 19, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC MINIMED Quick SerterNov 19, 2020
Manufacturer: SMC COSTA RICA DIVISION S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MIDAS REX® Legend® Surgical Dissecting ToolsNov 16, 2020
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
AZURE™ S DR MRI SureScan™Nov 15, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC External NeustimulatorNov 12, 2020
Manufacturer: MEDTRONIC NEUROMODULATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-MEDICUS Arterial Insertion KitNov 10, 2020
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LR-ACTNov 6, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CAPSTONE PTC™ Spinal SystemNov 4, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLARIA MRI™ CRT-D SureScan™Nov 4, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AMPLIA MRI Quad CRT-D SureScanNov 4, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Amplia MRI CRT-D SureScanNov 2, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
TA™ Auto Suture Stapler with DST Series™ TechnologyNov 1, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
TORQRNov 1, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
LIGASURE Blunt Tip Sealer/DividerNov 1, 2020
Manufacturer: COVIDIEN
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BELLCO Blood and Infusion lines for extracorporeal circulationOct 27, 2020
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AMPLIA MRI CRT-D SureScanOct 22, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Wide MRI Quad CRT-D SureScanOct 19, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FORCLEAN POLYPHE iOct 16, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INTERSTIM ICON Patient ProgrammerOct 16, 2020
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ACTIVE SCOct 16, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FORCE FX™ Electrosurgical Generator 8CS 240 VOct 16, 2020
Manufacturer: COVIDIEN Medical Products (Shanghai) Manufacturing LLC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
N'VISION Clinician ProgrammerOct 14, 2020
Manufacturer: MEDTRONIC NEUROMODULATION.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SONICISION Cordless Ultrasonic DissectionOct 12, 2020
Manufacturer: COVIDIEN.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ACT Easy Fill DeviceOct 12, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
FORCLEAN POLYPHE PLUSOct 12, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
RAPIDVAC Smoke EvacuatorOct 8, 2020
Manufacturer: BUFFALO FILTER LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
VALLEYLAB LS Series Single Channel Vessel SealingOct 7, 2020
Manufacturer: COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MANUFACTURING LLC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
CLARIA MRI Quad CRT-D SureScanOct 7, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
STREAMLINE Unipolar Pediatric Temporary Pacing LeadOct 6, 2020
Manufacturer: MEDTRONIC FABRICATION S.A.S.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Bio Console 560Oct 5, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Spinal NeedleOct 5, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
Claria MRI CRT-D SureScanOct 2, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
CARDIOBLATE BP2 Ablation DeviceSep 28, 2020
Manufacturer: CEA MEDICAL MANUFACTURING, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Angiographic Guide WireSep 24, 2020
Manufacturer: MEDTRONIC VASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORCLEAN THERAPY iSep 22, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Percutaneous Lead IntroducerSep 17, 2020
Manufacturer: MEDTRONIC INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SUPRA 17Sep 15, 2020
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
ENVEO R Loading SystemSep 12, 2020
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SAFE SHEATH (HLS series)Sep 12, 2020
Manufacturer: MERIT MEDICAL SYSTEMS INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC HR-HTCSep 9, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ASCENDA INTRATHECAL CATHETER 8780 SPINAL SEGMENTSep 6, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. JUNCOS
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Personal Therapy ManagerSep 6, 2020
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC RACTSep 4, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC HR-ACT Temperature CatridgesSep 2, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORMULA PlusAug 31, 2020
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EVERA MRI S DR SureScanAug 27, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
HFR17 (HFR Aequilibrium Therapy)Aug 24, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC MyCareLink Patient MonitorAug 24, 2020
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SUPRA 13Aug 21, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OLpur MD FilterAug 21, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORMULA 2000 PlusAug 21, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INTERSTIM Quadripolar Lead for Electrical StimulationAug 16, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
HEARTWARE WHAT CONTROLLERAug 11, 2020
Manufacturer: HEARTWARE, INC.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
FORCLEAN Therapy PlusAug 10, 2020
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BL352 Infusion Line Formula Therapy MID/HDFAug 10, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BELLCO Hollow fiber dialyzer BLS Series 500Aug 7, 2020
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
REVEAL XTAug 7, 2020
Manufacturer: MEDTRONIC EUROPE SARL.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORMULA PlusAug 7, 2020
Manufacturer: BELLCO S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORMULA TherapyAug 6, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FORMULA 2000 PlusAug 4, 2020
Manufacturer: BELLCO S.R.L.,
Class: Kelas : 2
Risk Class: Kelas Resiko : C
BELLCO Hollow fiber dialyzer BLS Series 800Aug 4, 2020
Manufacturer: BELLCO S.R.L
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SOLUCART PlusAug 3, 2020
Manufacturer: LABARATOIRE SOLUDIA S.A.S.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC MyCareLink Patient MonitorAug 3, 2020
Manufacturer: PLEXUS MANUFACTURING SDN. BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC MyCareLink Patient MonitorJul 23, 2020
Manufacturer: PLEXUS MANUFACTURING SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
CRYSTALLINE ACTFIX LeadJul 23, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SPRINTER LEGEND OTW Balloon Dilatation CatheterJul 22, 2020
Manufacturer: MEDTRONIC MEXICO S. DE R. L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
VALIANT NAVION™ Thoracic Stent Graft SystemJul 17, 2020
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
VISIA AF MRI XT VR SURESCANJul 12, 2020
Manufacturer: MEDTRONIC EUROPE S.A.R.L.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
EVEREST 20 Survival KitJul 3, 2020
Manufacturer: AVAILMED S.A. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Epicardial PatchJul 2, 2020
Manufacturer: MEDTRONIC INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Tunneling ToolJun 24, 2020
Manufacturer: MEDTRONIC, INC. Mounds View
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Reusable InstrumentJun 23, 2020
Manufacturer: MEDTRONIC SOFAMOR DANEK USA INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
PACIFIC Plus PTA CatheterJun 16, 2020
Manufacturer: INVATEC S.P.A.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PACIFIC XTREME PTA Balloon CatheterJun 16, 2020
Manufacturer: MEDTRONIC MEXICO S.DE R.L.DE C.V
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SELECTSITE Deflectable Catheter SystemJun 6, 2020
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 2
Risk Class: Kelas Resiko : C
QUICK-SET Infusion SetMay 29, 2020
Manufacturer: UNOMEDICAL DEVICES SA. OF C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Reservoir Paradigm Infusion PumpMay 28, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC NIM-ECLIPSE ControllerMay 24, 2020
Manufacturer: MEDTRONIC XOMED, INC
Class: Kelas : 2
Risk Class: Kelas Resiko : B
DURAN ANCORE Sizer SetMay 19, 2020
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Ventricular CathetersMay 17, 2020
Manufacturer: MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC MIDAS REX EHS SystemMay 17, 2020
Manufacturer: MEDTRONIC POWERED SURGICAL SOLUTIONS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
BIO-MEDICUS One Piece Femoral Veneous CannulaMay 15, 2020
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
OPUSMay 15, 2020
Manufacturer: MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Nerve Integrity Monitor (NIM) SystemMay 13, 2020
Manufacturer: MEDTRONIC XOMED, INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC DBS Patient ProgrammerMay 8, 2020
Manufacturer: MEDTRONIC NEUROMODULATION
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC COREVALVE EVOLUT R SystemMay 8, 2020
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
ENLITE Serter- MMT 7510May 6, 2020
Manufacturer: MEDTRONIC MINIMED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
DLP Tourniquet KitMay 1, 2020
Manufacturer: VIANT MEDICAL INC.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PASSERSApr 28, 2020
Manufacturer: MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
GUARDIAN REAL-Time Continuous Glucose Monitoring SystemApr 20, 2020
Manufacturer: MEDTRONIC MINIMED
Class: Kelas : 2
Risk Class: Kelas Resiko : C
iPro 2 Professional CGM SystemApr 17, 2020
Manufacturer: MEDTRONIC MINIMED.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
QUICK-SET PARADIGM Infusion SetApr 17, 2020
Manufacturer: UNOMEDICAL DEVICES SA. FROM. RESUME.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
iPort Advance ™ Injection PortApr 15, 2020
Manufacturer: UNOMEDICAL DEVICES S.A DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MIO Infusion SetApr 15, 2020
Manufacturer: UNOMEDICAL DEVICES S.A. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC XOMED Ventilation TubesApr 14, 2020
Manufacturer: MEDTRONIC XOMED INC
Class: Kelas : 2
Risk Class: Kelas Resiko : C
FlexiLux 200 LED, LED light source with Multi light guide adapterApr 2, 2020
Manufacturer: SCHOLLY FIBEROPTIC, GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
ENDEAVOR RESOLUTE Zotarolimus-Eluting Coronary Stent SystemMar 27, 2020
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DELTA Shunt KitMar 19, 2020
Manufacturer: MEDTRONIC NEUROSURGERY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AFFINITY PIXIE Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance BiosurfaceMar 9, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MAHURKAR Acute Dual Lumen Catheters and KitsMar 9, 2020
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS, S.A
Class: Kelas : 2
Risk Class: Kelas Resiko : C
AFFINITY Pediatric Arterial FilterMar 6, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Sil SerterMar 6, 2020
Manufacturer: SMC COSTA RICA DIVISION S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
AFFINITY Fusion OxygenatorMar 6, 2020
Manufacturer: MEDTRONIC PERFUSION SYSTEMS
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Quick SerterFeb 12, 2020
Manufacturer: SMC COSTA RICA DIVISION S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC CareLink Express MonitorFeb 3, 2020
Manufacturer: PLEXUS MANUFACTURING SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC CareLink Express MonitorFeb 3, 2020
Manufacturer: PLEXUS MANUFACTURING SDN., BHD.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
MEDTRONIC Restore Sensor SureScanJan 28, 2020
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS, JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
SHILEY Laryngeal MaskJan 21, 2020
Manufacturer: FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO., LTD.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC External Drainage and Monitoring Ventricular CatheterDec 12, 2019
Manufacturer: MEDTRONIC NEUROSURGERY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MULLINS Transseptal Catheter IntroducerDec 6, 2019
Manufacturer: AVAILMED S.A. DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
INPUT TS Introducer SheathNov 29, 2019
Manufacturer: AVAILMED S.A. DE C.V. (MEXICO)
Class: Kelas : 2
Risk Class: Kelas Resiko : B
REVEAL LINQ Insertion ToolsNov 27, 2019
Manufacturer: MEDTRONIC INC.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
NC SPRINTER Rapid Exchange Balloon Dilatation CatheterNov 19, 2019
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE CV
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC CSF-Unitized ShuntsNov 19, 2019
Manufacturer: MEDTRONIC NEUROSURGERY
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PROVIA Steerable GuidewireNov 19, 2019
Manufacturer: CEA GLOBAL DOMINICANA S.R.L.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SOLITAIRE™ Platinum Revascularization DeviceNov 19, 2019
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
EXPORT AP Aspiration CatheterNov 1, 2019
Manufacturer: MEDTRONIC VASCULAR
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SILHOUETTE PARADIGMOct 29, 2019
Manufacturer: UNOMEDICAL DEVICES S.A DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
SILHOUETTE PARADIGM ShortOct 28, 2019
Manufacturer: UNOMEDICAL DEVICES S.A DE C.V.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC Divergence Instrument- SterileOct 28, 2019
Manufacturer: MEDTRONIC SOFAMOR DANEK MANUFACTURING.
Class: Kelas : 1
Risk Class: Kelas Resiko : A
MEDTRONIC Capsure SP NovusSep 23, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
AMPHIRION DEEP PTA Balloon CatheterSep 6, 2019
Manufacturer: MEDTRONIC MEXICO S. DE R.L.DE C.V
Class: Kelas : 2
Risk Class: Kelas Resiko : C
INTEGRITY Rapid Exchange Coronary Stent SystemAug 30, 2019
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
DIVERGENCE™ Anterior Cervical Fusion SystemAug 28, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Class: Kelas : 2
Risk Class: Kelas Resiko : C
PALINDROME Precision Chronic Catheter and KitsAug 21, 2019
Manufacturer: COVIDIEN MANUFACTURING SOLUTIONS SA.
Class: Kelas : 2
Risk Class: Kelas Resiko : C
MEDTRONIC EVOLUT PRO SYSTEMAug 19, 2019
Manufacturer: MEDTRONIC MEXICO S. DE R.L. DE C.V.
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Restore Advance SureScanAug 13, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS, JUNCOS.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
EnVeo Pro Delivery Catheter SystemAug 13, 2019
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 3
Risk Class: Kelas Resiko : D
MEDTRONIC Subcutaneous Lead SystemJul 1, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA
Class: Kelas : 3
Risk Class: Kelas Resiko : D
Camera Head Full HD ZoomMay 31, 2019
Manufacturer: SCHOLLY FIBEROPTIC GMBH.
Class: Kelas : 2
Risk Class: Kelas Resiko : B
IN. PACT PACIFIC Paclitaxel-Eluting PTA Balloon CatheterMay 31, 2019
Manufacturer: MEDTRONIC IRELAND
Class: Kelas : 1
Risk Class: Kelas Resiko : D
Flexilux II LaparoscopeMay 31, 2019
Manufacturer: SCHOLLY FIBEROPTIC, GMBH
Class: Kelas : 2
Risk Class: Kelas Resiko : B
About this profile

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

Last updated: July 2026