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 103 05 19 000CLERADGAMMA SUPIIBfArM
mdprc 102 05 19 000CODAN Medizinische Geraete GmbH & Co KGArterial Blood Sampling SystemBfArM
mdprc 101 05 19 000Medtronic SAInterStim Therapy Programmer CompatibilityBfArM
mdprc 066 05 19 000LAWTON GmbH & Co., KGLeyla Flexible ArmsBfArM
mdprc 065 05 19 000GE HealthcareCT, PET-CT, and SPECT-CT Scanners BfArM
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 100 05 19 000GE HealthcareSenographe Pristina with SerenaNCMDR
mdprc 099 05 19 000GE HealthcareCentricity PACS‐IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10NCMDR
mdprc 098 05 19 000GE HealthcareCentricity Universal Viewer with PACS‐IW foundation 6.0 and Centricity PACS‐IWNCMDR
mdprc 088 05 19 000EKOS CorpEKOS Control System 4.0NCMDR
mdprc 071 05 19 000Abbotti-STAT BNP and CK-MB Control and Calibration Verification Control fluidsNCMDR
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 080 05 19 000PFIZER CONSUMER HEALTHCAREThermaCare Lower Back & Hip HeatwrapsSwissmedic
mdprc 079 05 19 000St. Jude Medical Inc.,Portico Solo Re-Collapsible Access SystemSwissmedic
mdprc 078 05 19 000SenTec AG.Membrane Changers and their InsertsSwissmedic
mdprc 077 05 19 000OLEA MEDICAL S.A.SOlea SphereSwissmedic
mdprc 076 05 19 000Sinapi Biomedical (Pty) LtdSinapi Chest DrainSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 113 04 19 001Integra LifeSciencesLimiTorr Volume Limiting External CSF Drainage and Monitoring Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172225
mdprc 092 05 19 000Change HealthcareMcKesson Cardiology Hemo Systemshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00745-1
mdprc 091 05 19 000MedicinaENFit NGP and Ryles Nasogastric Feeding Tubes https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00754-1
mdprc 090 05 19 000Beckman Coulter UK LtdPower Express Sample Processing Systemhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00756-1
mdprc 089 05 19 000Apollo Endosurgery Inc.Orbera Intragastric Balloon System and BIB Intragastric Balloon System https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00675-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 097 05 19 000Remel Inc.Thio Med w/o Ind, w/Dexhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172384
mdprc 096 05 19 000Neusoft Medical SystemsNeuViz 64 Multi-slice, 128 Multislice and 16 Essence Multislice CT Scanner System.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172628
mdprc 095 05 19 000Collagen Matrix, Inc. .Neomemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172146
mdprc 094 05 19 000KaVo Dental GmbHDEXIS Titanium Intraoral Sensorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172388
mdprc 093 05 19 000Remel Inc.Thio Med w/Dex, Hem, Vit, K (7ml) and (5ml)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172342