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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Competent Authorities Composite Listing
BfArM
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Reference NumberManufacturerDevice TypeReport Source
mdprc 091 09 18 000Alpha Omega Engineering Ltd.Neuro OmegaBfArM
mdprc 090 09 18 000Boston Scientific LATITUDE Programmer BfArM
mdprc 089 09 18 000Cordis CorporationPowerflex PRO PTA balloon dilation BfArM
mdprc 076 09 18 000Beckman CoulterEnzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98BfArM
mdprc 075 09 18 000Coltene Whaledent Inc.Unity Drill Assembly Unit, .021BfArM
Health Canada
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Reference NumberManufacturerDevice TypeReport Source
mdprc 065 05 15 000Roche Diagnostics LtdCANNABINOIDS II - ONLINE DAT and THC 2 http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52821r-eng.php
mdprc 107 03 15 000Midmark Corp.Progeny Vantage Panoramic X-Ray SystemHealthy Canadians
mdprc 116 02 15 000Terumo..Titan 360 StabilizerHealth_Canada
HPRA ( Formerly IMB )
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Reference NumberManufacturerDevice TypeReport Source
mdprc 077 03 16 001S. R. Smith, LLCSplash Pool LiftMHRA
mdprc 076 03 16 000BrainLABCranial Image-Guided Surgery (IGS) SystemHPRA
mdprc 075 03 16 000Fannin NI LtdW11024 BURKHOLDERIA CEPACIA SPECIFIC AGARHPRA
mdprc 074 03 16 000Eli Lilly ReoPro Filter kitHPRA
mdprc 073 03 16 000Pennine HealthcareOSC-1210/48, Clear Graduated Oppo-Cath Suction Catheter, 10ch/48cm.HPRA
MDCO
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Reference NumberManufacturerDevice TypeReport Source
mdprc 052 03 12 000Varian Medical SystemsRadiology, Therapy. 4D Integrated Treatment Console and TrueBeamMDCO
mdprc 002 03 12 000Thoratec CorpImplantable, Thoratec HeartMate II® Left Ventricular Assist System.http://www.mdco.gov.hk/english/recalls/recalls_20120228a.html
mdprc 144 02 12 000BD Diagnostic SystemsBD PrepStain Vacuum Pumpshttp://www.mdco.gov.hk/english/recalls/recalls_20120213.html
mdprc 057 02 12 000Terumo Cardiovascular Systems CorporationMonitoring, Terumo CDI™ Blood Parameter Monitoring System 500http://www.mdco.gov.hk/english/recalls/recalls_20120126a.html
mdprc 056 02 12 000Abbott Molecular Inc Sub Abbott LaboratoriesIVD, Scanner. Abbott Molecular Bar Code Scanner User's Guidehttp://www.mdco.gov.hk/english/recalls/recalls_20120202b.html
MHRA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 068 01 14 001ColoplastDuowire guidewire (AEBD35).MHRA
mdprc 081 07 11 001MedtronicDrug Infusion Pumps, SynchroMed® II ImplantableNCMDR
mdprc 158 11 16 000Wright Medical Technology, Inc.Wright VariousMHRA
mdprc 157 11 16 000Merz pharmceuticalsCellfina System Prep Pack CP1MHRA
mdprc 156 11 16 000Medtronic IncAffinity FusionTM Oxygenator with Integrated Arterial Filter and CVRMHRA
NCAR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 052 03 15 001DePuysynthes Pedicle Awl 4.0mm w/Canevasit Handle : Pedicle Awl 4.0mm w/Silicone HandleNCMDR
mdprc 078 09 15 000Eurovema ABMiniflex, Flexmobil, FormaNCAR
mdprc 045 09 15 000Intuitive Surgical IncVinci Xi Surgical SystemNCAR
mdprc 015 09 15 000DIALAB GmbHASONCAR
mdprc 212 08 15 000Handicare ABTransition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37NCAR
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 094 09 18 000Boston Scientific Cardiac Rhythm Management GroupCardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONENT™ and ESSENTIO™)NCMDR
mdprc 093 09 18 000Cooper Surgical, Inc.LONE STAR® SINGLE-USE ELASTIC STAYSNCMDR
mdprc 092 09 18 000Saudi Mais for Medical ProductsSterile single use Laryngeal Mask AirwayNCMDR
mdprc 083 09 18 000AbbottAlinity i Processing ModuleNCMDR
mdprc 082 09 18 000C R Bard Inc.HICKMAN Central Venous Catheter NCMDR
SFDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
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Reference NumberManufacturerDevice TypeReport Source
mdprc 078 09 18 000Sysmex Europe GmbH.Automated Hematology Analyser XN-SeriesSwissmedic
mdprc 077 09 18 000I2A - Intelligence Artificielle Applications SASIRscan discs Amoxicillin 2 μg + clavulanic acid 1 μgSwissmedic
mdprc 046 09 18 000Degania Silicone, LtdMon-a-Therm Foley catheters with temperature sensorsSwissmedic
mdprc 045 09 18 000Medtronic SAHeartWare Ventricular Assist Device ControllersSwissmedic
mdprc 044 09 18 000BioFire Diagnostics IncFilmArray Blood Culture Identification Panel-BCIDSwissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 088 09 18 000Abbott Laboratories ARCHITECT ICT Moduleshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01256-1
mdprc 087 09 18 000Baxter HealthcareAK 98 Hemodialysis Devices http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01233-1
mdprc 086 09 18 000Leica BOND Slide Labeller Zebra Printer Power Supply Unit (PSU) for use with BOND-lll and BOND-MAX instruments.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01254-1
mdprc 085 09 18 000Samsung ElectronicsSamsung Digital X-Ray System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00982-1
mdprc 084 09 18 000Siemens Healthcare Diagnostics ADVIA Chemistry Creatine Kinase (CK_L) System Reagent http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01271-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 098 09 18 000Vascular Technology, Inc.VTI 8 MHz Surgical Dopplerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165673
mdprc 097 09 18 000Sysmex America Inc (N/A)Sysmex Fluorocell PLThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166208
mdprc 096 09 18 000Medline Industries Inc.Medline 0.9 Sodium Chloride Injectionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166187
mdprc 095 09 18 000DePuy International LimitedP.F.C. SIGMA Revision Knee System Distal Augmenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166108
mdprc 063 09 18 000C R Bard IncUrine Collection BARD Midstream Catch Kit with Funnel Connectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165908