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Competent Authorities Composite Listing
BfArM
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 053 08 19 000 | SENTINEL CH. SpA | Lithium, Alinity c Lithium Reagent Kit | BfArM | | mdprc 052 08 19 000 | Remel Inc. | Salmonella paratyphi B-H phase 1 Flagellar antigen | BfArM | | mdprc 051 08 19 000 | Grace Medical Inc | Cartilage Microtome Systems and Cartilage Microtome Replacement Handles | BfArM | | mdprc 046 08 19 000 | SIEMENS | SOMATOM go.Up, go.NOW, go.TOP, go.ALL | BfArM | | mdprc 045 08 19 000 | Shimadzu Medical Systems. | Mobile X-Ray System MobileDaRt Evolution | BfArM |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 055 08 19 000 | SIEMENS | Cellognost Echinococcosis | NCMDR | | mdprc 054 08 19 000 | ICU Medical, Inc | Plum & Sapphire Microbore Infusion Sets with Inline Filters | NCMDR | | mdprc 049 08 19 000 | Philips Healthcare | Efficia DFM100 Defibrillator/Monitor | NCMDR | | mdprc 048 08 19 000 | Medtronic | Medtronic Micra™ Delivery System | NCMDR | | mdprc 047 08 19 000 | GE Healthcare | Proteus XR/a fixed RAD systems | 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 078 05 19 001 | SenTec AG. | Membrane Changers and their Inserts | US. FDA | | mdprc 026 08 19 000 | Occlutech Holding AG | Occlutech Delivery Set.. | Swissmedic | | mdprc 025 08 19 000 | Siemens Healthcare Diagnostics GmbH | Dimension Ferritin Flex reagent cartridge | Swissmedic | | mdprc 024 08 19 000 | Intersurgical Limited | Various Breathing Systems and Components | Swissmedic | | mdprc 023 08 19 000 | Air Liquide Medical Systems | MONNAL T60, T60 JP, T75, T75 JP, T75 CO2 , T50, T50 JP, T50 DE , T40, T40 DE | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 038 08 18 001 | Medtronic | BIS Vista and BIS View Monitoring Systems | NCMDR | | mdprc 012 07 19 001 | Varian Medical Systems | Stainless Steel Interstitial Needles, 17 Gauge | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01003-1 | | mdprc 008 03 19 001 | Biomet 3i Inc. | 3.4mm Certain BellaTek Abutment, ILDAT3 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171233 | | mdprc 089 05 19 001 | 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 | | mdprc 009 08 19 000 | SIEMENS | MAMMOMAT Revelation VC10 with Biopsy Option | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01129-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 050 08 19 000 | Integra LifeSciences | Codman ISOCOOL Bipolar Forceps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175411 | | mdprc 043 08 19 000 | Centurion Medical Products | Various Products: Speculum, vaginal, metal, Dressing tray, Circumcision tray | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174737 | | mdprc 042 08 19 000 | Ortho-Clinical Diagnostics | VITROS 250, 250AT, 350, 4600, 5600 and 5,1 FS chemistry systems. clinical chemistry analyzer | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174829 | | mdprc 041 08 19 000 | Ortho-Clinical Diagnostics | VITROS Chemistry Products GLU Slides | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174082 | | mdprc 040 08 19 000 | Ad-Tech Medical Instrument Corp | LSB Style Anchor Bolt | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174373 |
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