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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 054 03 18 001Keystone Dental IncStage-1 Tissue Punch, Disposable, 4.5mmBfArM, FDA https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162775
mdprc 061 04 18 000Becton Dickinson & Co. (BD)BD Vacutainer Citrate Plus Blood Collection TubesBfArM
mdprc 060 04 18 000BD Diagnostic SystemsVIASURE Flu A, Flu B and RSV Real Time PCR Detection Kit to be used by BD MAXBfArM
mdprc 059 04 18 000FEG Textiltechnik Forschungs-und Entwicklungsgesellschaft mbHDynaMesh PR2 soft 2B , DynaMesh PR4 soft 2BBfArM
mdprc 058 04 18 000First Global Enterprises LimitedOxygen Mask for adult, high concentration, non‐rebreather/AsidBonzBfArM
Health Canada
Please click on an item below to view.
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 )
Please click on an item below to view.
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
Please click on an item below to view.
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
Please click on an item below to view.
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
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 099 04 18 000MedtronicCovidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series TechnologyNCMDR
mdprc 097 04 18 000ArjoHuntleighEntroy Pool LiftersNCMDR
mdprc 096 04 18 000St. Jude Medical IncBattery Performance Alert and Cybersecurity Firmware Updates for Certain ICD & CRT-D DevicesNCMDR
mdprc 095 04 18 000Alrazi Pharma IndustriesLiquid Acid Concentrate for Haemodialysis-HDA08NCMDR
mdprc 094 04 18 000AesculapSurgical PENIS CLAMPNCMDR
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 082 04 18 000Becton Dickinson & Co. (BD)BD Vacutainer EDTA tubes, BD Vacutainer Lithium Heparin tubesSwissmedic
mdprc 081 04 18 000MRC-HollandSALSA MLPA Probemix P060 SMASwissmedic
mdprc 080 04 18 000Siemens Healthcare Diagnostics ProductAtellica COAG 360Swissmedic
mdprc 079 04 18 000Bio-Rad Laboratories IncMueller HintonSwissmedic
mdprc 078 04 18 000Becton, Dickinson And CompanyAlaris SMARTSITE ADD-ON BAG ACCESS DEVICESwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 101 04 18 000Stryker MedtechSonopet Ultrasonic Products http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00323-1
mdprc 100 04 18 000Gyrus ACMIClassic Series Reusable Active Cord designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00326-1
mdprc 092 04 18 000Edwards LifesciencesIntraClude Intra-aortic Occlusion Device http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00313-1
mdprc 091 04 18 000Phadia ABEliA Intrinsic Factor Well http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00317-1
mdprc 090 04 18 000Philips HealthcarePhilips Ingenuity Core (728321)http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00312-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 108 04 18 000Ace Surgical Supply Co., IncDouble Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163464
mdprc 107 04 18 000Cook Medical Cook Vacuum Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163165
mdprc 106 04 18 000Integra LifeSciencesTITANhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162744
mdprc 105 04 18 000Life Technologies Limited.Oncomine Dx Target Test.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162895
mdprc 104 04 18 000Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1 Flow Module.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162847