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Competent Authorities Composite Listing
BfArM
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 103 05 19 000 | CLERAD | GAMMA SUPII | BfArM | | mdprc 102 05 19 000 | CODAN Medizinische Geraete GmbH & Co KG | Arterial Blood Sampling System | BfArM | | mdprc 101 05 19 000 | Medtronic SA | InterStim Therapy Programmer Compatibility | BfArM | | mdprc 066 05 19 000 | LAWTON GmbH & Co., KG | Leyla Flexible Arms | BfArM | | mdprc 065 05 19 000 | GE Healthcare | CT, PET-CT, and SPECT-CT Scanners | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 100 05 19 000 | GE Healthcare | Senographe Pristina with Serena | NCMDR | | mdprc 099 05 19 000 | GE Healthcare | Centricity PACS‐IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10 | NCMDR | | mdprc 098 05 19 000 | GE Healthcare | Centricity Universal Viewer with PACS‐IW foundation 6.0 and Centricity PACS‐IW | NCMDR | | mdprc 088 05 19 000 | EKOS Corp | EKOS Control System 4.0 | NCMDR | | mdprc 071 05 19 000 | Abbott | i-STAT BNP and CK-MB Control and Calibration Verification Control fluids | NCMDR |
SFDA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 126 05 18 000 | Philips Healthcare | HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs | SFDA |
Swissmedic
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 080 05 19 000 | PFIZER CONSUMER HEALTHCARE | ThermaCare Lower Back & Hip Heatwraps | Swissmedic | | mdprc 079 05 19 000 | St. Jude Medical Inc., | Portico Solo Re-Collapsible Access System | Swissmedic | | mdprc 078 05 19 000 | SenTec AG. | Membrane Changers and their Inserts | Swissmedic | | mdprc 077 05 19 000 | OLEA MEDICAL S.A.S | Olea Sphere | Swissmedic | | mdprc 076 05 19 000 | Sinapi Biomedical (Pty) Ltd | Sinapi Chest Drain | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 113 04 19 001 | Integra LifeSciences | LimiTorr Volume Limiting External CSF Drainage and Monitoring Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172225 | | mdprc 092 05 19 000 | Change Healthcare | McKesson Cardiology Hemo Systems | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00745-1 | | mdprc 091 05 19 000 | Medicina | ENFit 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 19 000 | Beckman Coulter UK Ltd | Power Express Sample Processing System | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00756-1 | | mdprc 089 05 19 000 | Apollo 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 Number | Manufacturer | Device Type | Report Source |
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| mdprc 097 05 19 000 | Remel Inc. | Thio Med w/o Ind, w/Dex | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172384 | | mdprc 096 05 19 000 | Neusoft Medical Systems | NeuViz 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 19 000 | Collagen Matrix, Inc. . | Neomem | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172146 | | mdprc 094 05 19 000 | KaVo Dental GmbH | DEXIS Titanium Intraoral Sensor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172388 | | mdprc 093 05 19 000 | Remel Inc. | Thio Med w/Dex, Hem, Vit, K (7ml) and (5ml) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172342 |
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