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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 066 10 18 001 | DT MedTech | H3 Poly Inlay | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168103 | | mdprc 044 11 18 000 | OSTEOGENICS BIOMEDICAL,INC. . | ZCORE Porcine Xenograft Particulate | BfArM | | mdprc 043 11 18 000 | Southmedic Inc | Uresta Bladder Support | BfArM | | mdprc 042 11 18 000 | Molnlycke Health Care AB. | Mölnlycke® Suction & Irrigation Set | BfArM | | mdprc 041 11 18 000 | Gebr. Brasseler GmbH & Co KG (Business Unit Komet Medical) | Saw blades for bone surgery for single use -STERILE | BfArM |
Health Canada
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HPRA ( Formerly IMB )
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 077 03 16 001 | S. R. Smith, LLC | Splash Pool Lift | MHRA | | mdprc 076 03 16 000 | BrainLAB | Cranial Image-Guided Surgery (IGS) System | HPRA | | mdprc 075 03 16 000 | Fannin NI Ltd | W11024 BURKHOLDERIA CEPACIA SPECIFIC AGAR | HPRA | | mdprc 074 03 16 000 | Eli Lilly | ReoPro Filter kit | HPRA | | mdprc 073 03 16 000 | Pennine Healthcare | OSC-1210/48, Clear Graduated Oppo-Cath Suction Catheter, 10ch/48cm. | HPRA |
MDCO
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 052 03 12 000 | Varian Medical Systems | Radiology, Therapy. 4D Integrated Treatment Console and TrueBeam | MDCO | | mdprc 002 03 12 000 | Thoratec Corp | Implantable, Thoratec HeartMate II® Left Ventricular Assist System. | http://www.mdco.gov.hk/english/recalls/recalls_20120228a.html | | mdprc 144 02 12 000 | BD Diagnostic Systems | BD PrepStain Vacuum Pumps | http://www.mdco.gov.hk/english/recalls/recalls_20120213.html | | mdprc 057 02 12 000 | Terumo Cardiovascular Systems Corporation | Monitoring, Terumo CDI™ Blood Parameter Monitoring System 500 | http://www.mdco.gov.hk/english/recalls/recalls_20120126a.html | | mdprc 056 02 12 000 | Abbott Molecular Inc Sub Abbott Laboratories | IVD, Scanner. Abbott Molecular Bar Code Scanner User's Guide | http://www.mdco.gov.hk/english/recalls/recalls_20120202b.html |
MHRA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 113 10 18 000 | Roche Diagnostics Corp | AccuChek Aviva Plus Test Strip | MHRA | | mdprc 068 01 14 001 | Coloplast | Duowire guidewire (AEBD35). | MHRA | | mdprc 081 07 11 001 | Medtronic | Drug Infusion Pumps, SynchroMed® II Implantable | NCMDR | | mdprc 158 11 16 000 | Wright Medical Technology, Inc. | Wright Various | MHRA | | mdprc 157 11 16 000 | Merz pharmceuticals | Cellfina System Prep Pack CP1 | MHRA |
NCAR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 052 03 15 001 | DePuysynthes | Pedicle Awl 4.0mm w/Canevasit Handle : Pedicle Awl 4.0mm w/Silicone Handle | NCMDR | | mdprc 078 09 15 000 | Eurovema AB | Miniflex, Flexmobil, Forma | NCAR | | mdprc 045 09 15 000 | Intuitive Surgical Inc | Vinci Xi Surgical System | NCAR | | mdprc 015 09 15 000 | DIALAB GmbH | ASO | NCAR | | mdprc 212 08 15 000 | Handicare AB | Transition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37 | NCAR |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 052 11 18 000 | Philips Healthcare | Efficia 3/5 ECG Trunk Cable, AAMI/IEC | NCMDR | | mdprc 071 04 18 001 | Draeger Medical Systems Inc | Jaundice Meter JM-103 and JM-105 Out of Range Indication | NCMDR | | mdprc 103 07 18 001 | Ortho-Clinical Diagnostics | VITROS MicroWell Assays | Swissmedic | | mdprc 035 11 18 000 | Abbott Diagnostic International Ltd | G-Series, E-Series and BCM SCC RAM Inspection and Installation | NCMDR | | mdprc 034 11 18 000 | Siemens Medical Solutions | Image orientation labels with scenario. | 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 039 11 18 000 | Tecan | Androstenedione ELISA | Swissmedic | | mdprc 029 11 18 000 | Telemis S.A. | Telemis-Medical Software | Swissmedic | | mdprc 028 11 18 000 | Linkage Biosciences Inc. | LinkSeq HLA | Swissmedic | | mdprc 027 11 18 000 | The Binding Site | Human IgM Kit for use on SPAPLUS | Swissmedic | | mdprc 026 11 18 000 | Ortho-Clinical Diagnostics | VITROS 3600, 4600, 5600, 7600 & 5,1FS | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 038 11 18 000 | Carestream Health | Kodak DirectView DR 7500 System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01434-1 | | mdprc 037 11 18 000 | Cambridge Nutritional Sciences Ltd | FoodPrint Microarray 200+ Food IgG. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01431-1 | | mdprc 036 11 18 000 | BioArray Solutions Ltd. | HEA Precise Type Beadchip Kit and RHD Beadchip Kit, CE. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01435-1 | | mdprc 017 11 18 000 | Argon Medical Devices | 4-Way Stopcock w/MLL, Adapter DBL Male and Female LL | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01423-1 | | mdprc 005 11 18 000 | Carl Zeiss | Plex Elite 9000 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01414-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 051 11 18 000 | Safe N Simple, LLC | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167530 | | mdprc 050 11 18 000 | Medtronic SA | Medtronic Navigation | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168363 | | mdprc 049 11 18 000 | Integrity Implants Inc. | FlareHawk | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167968 | | mdprc 048 11 18 000 | Fannin UK Ltd | Espiner Tissue Retrieval System.. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167206 | | mdprc 047 11 18 000 | BioFire Diagnostics Inc | BioFire FilmArray Meningitis/Encephalitis (ME) Panel | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167757 |
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