X
OK Your changes have been successfully saved
SFDA Home Page
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 008 01 22 000Jafron Biomedical Co.,LtdDisposable Hemoperfusion Cartridge (HA)BfArM
mdprc 005 01 22 000MAQUET Cardiopulmonary GmbHTubing setsBfArM
mdprc 018 12 21 000Accelerate Diagnostics IncAccelerate Pheno system..BfArM
mdprc 017 12 21 000Hain Lifescience GmbH.GenoType MTBDRplus Ver 2.0 / GenoType MTBDRsl 2.0/2,0BfArM
mdprc 016 12 21 000Natus NeurologyIPELA FHD PTZ TILE KITSBfArM
mdprc 012 12 21 000Leica Biosystems NewcastleBOND Epitope Retrieval Solution 1 & 2, BOND Wash Solution 1OX ConcentrateBfArM
mdprc 009 12 21 000MEDE TechnikK-WIRES 15cm ⌀1,4mm TR/RDBfArM
mdprc 035 11 21 000SPINEART SAPolyaxial Perla Screw Ø3.5BfArM
mdprc 016 02 21 002Nuvasive Specialized Orthopaedics Inc.All Precice System DevicesBfArM, NCMDR
mdprc 033 10 21 000Lumenis IncEcoGel 200BfArM
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 017 01 22 000Arrow International Inc.Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device, Arrow-Trerotola PTD Set Percutaneous Thrombolytic Device, Arrow-Trerotola Kit Percutaneous Thrombolytic DeviceNCMDR
mdprc 015 01 22 000Roche Diagnostics GmbH.BENCHMARK ULTRA STAINER MODULE, DISCOVERY ULTRA (RUO)NCMDR
mdprc 014 01 22 000Medtronic SAEndurant II/IIs Stent Graft SystemNCMDR
mdprc 013 01 22 000Baxter HealthcareMiniCap Extended Life PD Transfer SetsNCMDR
mdprc 012 01 22 000B Braun Medical Inc.Perfusor SpaceNCMDR
mdprc 011 01 22 000B. Braun Avitum AGDialog dialysis machineNCMDR
mdprc 010 01 22 000Becton Dickinson & Co. (BD)BD Veritor Plus AnalyzerNCMDR
mdprc 006 01 22 000Intuitive Surgical Inc.da Vinci Xi and da Vinci X 12-8 mm Cannula ReducersNCMDR
mdprc 025 12 21 000GE HealthcareGE Healthcare MRI systemsNCMDR
mdprc 023 12 21 000LISA Laser Products GmbHSideFib-SUNCMDR
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 016 01 22 000Liko ABLiko M220, Liko M230Swissmedic
mdprc 002 03 21 001OlympusOLYMPUS DUODENOVIDEOSCOPE, OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE, EVIS LUCERA ELITE DUODENOVIDEOSCOPE, and SINGLE USE DISTAL COVERSwissmedic, BfArM
mdprc 004 01 22 000MAQUET Cardiopulmonary GmbHHeater-Cooler Unit HCU 40.Swissmedic
mdprc 002 01 22 003D.O.R.C. Dutch Opthalmic Research CenterEFTIAR Octane, syringes and vial, 5 ml and 7 mlSwissmedic
mdprc 001 01 22 000AbbottAlinity m SystemSwissmedic
mdprc 027 12 21 000AbbottAlinity m SystemSwissmedic
mdprc 024 12 21 000ViennaLab Diagnostics GmbHα-Globin StripAssay REF 4-160Swissmedic
mdprc 012 06 21 001Abbott Point of Carei-STAT CG8+ cartridges, i-STAT EG7+ cartridgesSwissmedic, NCMDR
mdprc 005 02 20 006Roche Diagnostics CorpElecsys CA 19-9NCMDR
mdprc 013 12 21 000Nuvasive Specialized Orthopaedics Inc.MAGEC Device SystemSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 018 01 22 000Philips HealthcarePhilips Fetal Spiral Electrodehttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02432-1
mdprc 009 01 22 000Shimadzu CorporationShimadzu Sonialvision G4 and Sonialvision Safire 17https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02429-1
mdprc 007 01 22 000Bio Rad.Trimethoprim Sulfametoxazole 1.25-23.75 µg diskhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02418-1
mdprc 003 01 22 000Phadia LtdImmunoCAP Total IgE, ImmunoCAP Specific IgE and ViewAllergyhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02361-1
mdprc 022 12 21 000Draeger Medical Systems IncPerseus A500 Anesthesia workstation ceiling mounted versionhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02378-1
mdprc 021 12 21 000Draeger Medical Systems IncBabyleo TN500 IncuWarmerhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02270-1
mdprc 033 11 21 001AMO Manufacturing USA, LLCCATALYS Precision Laser System and iDESIGN Refractive StudioTGA, Swissmedic
mdprc 001 12 21 000OlympusTJF-Q180V duodenoscopeshttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02057-1
mdprc 018 11 21 000Bio Rad.BioPlex 2200 APLS IgM and BioPlex 2200 APLS IgAhttps://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02166-1
mdprc 009 11 21 000The Binding SiteFreelite Human Lambda Free Kit (for use on the SPAPLUS)https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2021-RN-02087-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 026 12 21 000Wright Medical Technology, Inc.Stryker CLAW II ORTHOLOC and Stryker DARCO Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190461
mdprc 019 11 21 000Hitachi Ltd.Arietta 850 Ultrasound; Lisendo 880 Ultrasoundhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189705
mdprc 015 11 21 000Dentech Corp.Rubber Dam Clamp, KSKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187238
mdprc 022 09 21 000Siemens Healthcare Diagnostics, IncAtellica IM BR 27.29 (BR) Assay 250 Test KitUS. FDA
mdprc 009 09 21 000Hitachi Medical CorpECHELON MRI Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188704
mdprc 033 08 21 000Pentax of America IncPentax Medical Video DuodenoscopeFDA
mdprc 007 08 21 000Sunrise MedicalZippie Voyagehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188302
mdprc 001 08 21 000Siemens Healthcare DiagnosticsADVIA Chemistry XPT Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187838
mdprc 003 07 21 000Quidel CorporationLyra SARSCoV2 Assay (M120) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187617
mdprc 033 06 21 000Fujifilm Medical Systems U.S.A., Inc.Synapse PACS - Radiological Image Processing Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=186333