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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
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 062 10 18 001Richard Wolf GmbHTEXAS Bronchoscope TubeBfArM, NCMDR
mdprc 057 11 18 001Civco Medical Instruments IncL25 Needle Guide Brackethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168897
mdprc 050 12 18 000curasan AGCuravisc, Hyaluronic Acid 1%BfArM
mdprc 049 12 18 000Elekta IncMOSAIQ release version 2.64 SP9 and higherBfArM
mdprc 048 12 18 000Henry Schein, Inc..Henry Schein CU-1000 Halogen LightBfArM
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
Please click on an item below to view.
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 113 10 18 000Roche Diagnostics CorpAccuChek Aviva Plus Test StripMHRA
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
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 055 12 18 000Elekta Inc.MOSAIQ Radiation Oncology NCMDR
mdprc 036 12 18 000Ethicon Inc.PROXIMATE Hemorrhoidal Circular StaplerNCMDR
mdprc 035 12 18 000Siemens Healthcare Diagnostics GmbHAtellica IM Anti-Thyroglobulin (aTG) Positive BiasNCMDR
mdprc 034 12 18 000Siemens Healthcare Diagnostics GmbHADVIA Centaur Anti-Thyroglobulin (aTG) Positive Bias, ADVIA Centaur, XP, XPT and CPNCMDR
mdprc 033 12 18 000AbbottCP3000 w/ CTS and w/o CTS 230VNCMDR
SFDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 087 12 17 001Boston Scientific Cardiac Rhythm Management GroupVALITUDE CRT-P, ALTRUA 2 Pacemaker, ESSENTIO Pacemaker, ACCOLADE Pacemaker, PROPONENT Pacemaker , VISIONIST CRT-PBfArM
mdprc 021 12 18 000BonesupportCERAMENT G, CERAMENT BONE VOID FILLER and CERAMENT VSwissmedic
mdprc 020 12 18 000BIOHIT OYJLactose intolerance quick testSwissmedic
mdprc 019 12 18 000Gambro Lundia ABCWP 800 RO1 220-240V/ 380-415V 50Hz, CWP 800 HW 220-240V/ 380-415V 50Hz, Clinic PanelSwissmedic
mdprc 078 11 18 000Alere Scarborough, Inc.Alere BinaxNOW Legionella with the Alere ReaderSwissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 101 11 18 001Medtronic Suction/Anticoagulation Assembly LinesBfArM
mdprc 002 12 18 002Medtronic Medtronic HeartWare HVAD System Battery Charger https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169057
mdprc 028 12 18 000Cis Bio InternationalCisbio - Chromogranin A (CGA-ELISA) http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01522-1
mdprc 027 12 18 000Shimadzu Medical Systems.Digital Angiography System Trinias http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01487-1
mdprc 026 12 18 000Synovis Micro Companies Alliance Inc. Synovis GEM4183C Coupler Forcepshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01519-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 054 12 18 000Zimmer, INC…. Comprehensive Mini Stem, Orthopedic Salvage System (OSS)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168913
mdprc 053 12 18 000Tosoh CorporationAIA360https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167366
mdprc 052 12 18 000Leoni Fiber Optics GmbHLaser Fiber Assy-Single Usehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168872
mdprc 051 12 18 000Arjo IncFlite Clip Sling, 4 Pointhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168967
mdprc 030 12 18 000Pfizer LimitedVarious Thermacare Heat Wrapshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167683