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Competent Authorities Composite Listing
BfArM
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 003 07 19 001 | Edwards Lifesciences | IntraClude Intra-Aortic Occlusion Devices | NCMDR | | mdprc 055 07 19 000 | Fast Track Diagnostics Luxembourg S.à.r.l. | FTD Neuro 9 | BfArM | | mdprc 054 07 19 000 | Fast Track Diagnostics Luxembourg S.à.r.l. | FTlyo diverse | BfArM | | mdprc 053 07 19 000 | Ortho-Clinical Diagnostics | ORTHO AutoVue Innova Ultra & VISION or VISION Max | BfArM | | mdprc 052 07 19 000 | Samsung Electronics | Ultrasonic Diagnostic Apparatus WS80A and HS70A | BfArM |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 061 07 19 000 | Abbott | Alinity c Lithium Reagent Kit | NCMDR | | mdprc 060 07 19 000 | Roche Diagnostics | ONLINE TDM Vancomycin Gen.3 (VANC3) | NCMDR | | mdprc 040 07 19 000 | Elekta Inc. | Monaco | NCMDR | | mdprc 039 07 19 000 | Zimmer Surgical, Inc | Pulsavac® Plus Wound Debridement Systems | NCMDR | | mdprc 037 07 19 000 | Statcorp Medical | UltraCheck ABP Blood Pressure Cuffs | 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 032 07 19 000 | Amplitude GmbH | Broach Handle | Swissmedic | | mdprc 031 07 19 000 | GBUK Enteral Ltd also trading as Enteral UK | Nutricare Infant Clear Nasogastric Feeding Tube 6Fr 50cm Sterile | Swissmedic | | mdprc 030 07 19 000 | Edwards Lifesciences | Edwards CENTERA Transcatheter Heart Valve System | Swissmedic | | mdprc 029 07 19 000 | Oertli Instrumente AG | TITANIUM TIP EASYTIP 2.2MM 30° | Swissmedic | | mdprc 024 07 19 000 | REPROLIFE | Warming Solution Set 205, Warming Kit 102, Vitrification Solution Set 110, Vitrification Kit 101 | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 031 03 19 001 | BioFire Diagnostics Inc. | FilmArray Gastrointestinal (GI) Panel. | NCMDR | | mdprc 064 07 19 000 | Getinge | GETINGE Steam Steriliser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01071-1 | | mdprc 043 07 19 000 | Phadia Ltd | Phadia 1000 instrument | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01055-1 | | mdprc 042 07 19 000 | Morcher GmbH | Morcher Capsular Tension Rings Type 13 Right, Type 13A Right and Type 13B Right | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00995-1 | | mdprc 041 07 19 000 | BD Biosciences | BD Connecta Plus3 White (3 way stopcock) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01049-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 065 07 19 000 | DeRoyal Industries Inc. | CRANI PACK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173848 | | mdprc 063 07 19 000 | Teleflex Medical.. | HUDSON RDI NEONATAL ConchaSmart Breathing Circuit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173297 | | mdprc 062 07 19 000 | Cooper Surgical, Inc. | Advincula Delineator Uterine Manipulators with Soft Koh-Efficient , | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173714 | | mdprc 059 07 19 000 | Pharmaceutical Innovations, Inc. | ElectroMist | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174062 | | mdprc 058 07 19 000 | GE Healthcare | Ultrasound Probe RIC59D and Repair RIC59ARS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174509 |
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