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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 066 10 18 001DT MedTechH3 Poly Inlayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168103
mdprc 044 11 18 000OSTEOGENICS BIOMEDICAL,INC. .ZCORE Porcine Xenograft ParticulateBfArM
mdprc 043 11 18 000Southmedic IncUresta Bladder SupportBfArM
mdprc 042 11 18 000Molnlycke Health Care AB.Mölnlycke® Suction & Irrigation SetBfArM
mdprc 041 11 18 000Gebr. Brasseler GmbH & Co KG (Business Unit Komet Medical)Saw blades for bone surgery for single use -STERILE BfArM
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 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 052 11 18 000Philips HealthcareEfficia 3/5 ECG Trunk Cable, AAMI/IECNCMDR
mdprc 071 04 18 001Draeger Medical Systems IncJaundice Meter JM-103 and JM-105 Out of Range IndicationNCMDR
mdprc 103 07 18 001Ortho-Clinical DiagnosticsVITROS MicroWell AssaysSwissmedic
mdprc 035 11 18 000Abbott Diagnostic International LtdG-Series, E-Series and BCM SCC RAM Inspection and InstallationNCMDR
mdprc 034 11 18 000Siemens Medical SolutionsImage orientation labels with scenario.NCMDR
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 039 11 18 000Tecan Androstenedione ELISA Swissmedic
mdprc 029 11 18 000Telemis S.A.Telemis-Medical Software Swissmedic
mdprc 028 11 18 000Linkage Biosciences Inc.LinkSeq HLASwissmedic
mdprc 027 11 18 000The Binding SiteHuman IgM Kit for use on SPAPLUS Swissmedic
mdprc 026 11 18 000Ortho-Clinical DiagnosticsVITROS 3600, 4600, 5600, 7600 & 5,1FS Swissmedic
TGA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 038 11 18 000Carestream HealthKodak DirectView DR 7500 System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01434-1
mdprc 037 11 18 000Cambridge Nutritional Sciences LtdFoodPrint Microarray 200+ Food IgG.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01431-1
mdprc 036 11 18 000BioArray Solutions Ltd.HEA Precise Type Beadchip Kit and RHD Beadchip Kit, CE. http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01435-1
mdprc 017 11 18 000Argon Medical Devices4-Way Stopcock w/MLL, Adapter DBL Male and Female LL http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01423-1
mdprc 005 11 18 000Carl Zeiss Plex Elite 9000 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01414-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 051 11 18 000Safe N Simple, LLCSimpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167530
mdprc 050 11 18 000Medtronic SAMedtronic Navigationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168363
mdprc 049 11 18 000Integrity Implants Inc.FlareHawkhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167968
mdprc 048 11 18 000Fannin UK LtdEspiner Tissue Retrieval System..https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167206
mdprc 047 11 18 000BioFire Diagnostics IncBioFire FilmArray Meningitis/Encephalitis (ME) Panelhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167757