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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 021 03 19 001 | DiaSys Diagnostic Systems GmbH. | Reagent CRP FS | Swissmedic | | mdprc 120 09 19 000 | W.O.M. World of Medicine GmbH (hereafter “WOM” . | Aquilex Fluid Control Systems | BfArM | | mdprc 119 09 19 000 | Ecken & Ziegler BEBIG GmbH | Ru-106 Augenapplikatoren | BfArM | | mdprc 108 09 19 000 | Quality Electrodynamics, LLC (QED) | TxRx Knee Coil 1.5T and 3T for Use on Siemens MR Systems | BfArM | | mdprc 107 09 19 000 | JSC "MEDSIL" | Medsil Intragastric Balloon | BfArM |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 078 06 19 002 | Roche Diagnostics Corp | Tina-quant Myoglobin Gen.2 MYO2 | Swissmedic | | mdprc 089 10 18 001 | Medtronic | CareLink 2090 and CareLink Encore 29901/29901A Programmers | NCMDR | | mdprc 112 09 19 000 | Philips Healthcare | V60 and V600 Ventilator | NCMDR | | mdprc 111 09 19 000 | Medtronic | CT900 Clinician Programmer | NCMDR | | mdprc 110 09 19 000 | HUMAN Gesellschaft für Biochemica und Diagnostica GmbH | IM Quick Test | NCMDR |
SFDA
Please click on an item below to view.
| 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
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 020 08 19 001 | Radiometer America Inc | AQURE system.. | Swissmedic | | mdprc 073 03 19 001 | Olympus | MAJ-209 Single-Use Suction Valve | NCMDR | | mdprc 087 09 19 000 | Dedienne Santé | SYMBOL CUP DM: SCREW | Swissmedic | | mdprc 086 09 19 000 | Caesarea Medical Electronics Ltd | T34 Ambulatory Syringe Pumps | Swissmedic | | mdprc 085 09 19 000 | Thoratec Corp | CentriMag Motors | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 118 09 19 000 | OriGen Biomedical | OriGen Products TissueVault O-Wrap and accessories | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01361-1 | | mdprc 117 09 19 000 | Medifab Medical Fabrication | Shuttle Discovery with 4 Wheel Verve Stroller | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01325-1 | | mdprc 116 09 19 000 | MAQUET Cardiopulmonary | VHK and VKMO(D) Adult/Small Adult Accessories | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01380-1 | | mdprc 115 09 19 000 | MAQUET Cardiopulmonary | VHK and VKMO Adult/Small Adult | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01381-1 | | mdprc 114 09 19 000 | CODAN | Swan-Lock Needle-Free Connector | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-01362-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 098 09 19 000 | MAQUET Cardiopulmonary GmbH | HLS Set Advanced 7.0 Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174814 | | mdprc 097 09 19 000 | Ad-Tech Medical Instrument Corp | ADTECH Drill Sleeve Guides | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175964 | | mdprc 094 09 19 000 | Dynex Technologies Ltd | Dynex DSX Instrument | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175187 | | mdprc 093 09 19 000 | Exactech | Threaded Offset Cup Impactor | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175607 | | mdprc 092 09 19 000 | Teleflex Medical.. | Hudson RCI Sheridan LTS | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175293 |
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