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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 091 09 18 000 | Alpha Omega Engineering Ltd. | Neuro Omega | BfArM | | mdprc 090 09 18 000 | Boston Scientific | LATITUDE Programmer | BfArM | | mdprc 089 09 18 000 | Cordis Corporation | Powerflex PRO PTA balloon dilation | BfArM | | mdprc 076 09 18 000 | Beckman Coulter | Enzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98 | BfArM | | mdprc 075 09 18 000 | Coltene Whaledent Inc. | Unity Drill Assembly Unit, .021 | 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
Please click on an item below to view.
| 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 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 | | mdprc 156 11 16 000 | Medtronic Inc | Affinity FusionTM Oxygenator with Integrated Arterial Filter and CVR | MHRA |
NCAR
Please click on an item below to view.
| 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
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 094 09 18 000 | Boston Scientific Cardiac Rhythm Management Group | Cardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONENT™ and ESSENTIO™) | NCMDR | | mdprc 093 09 18 000 | Cooper Surgical, Inc. | LONE STAR® SINGLE-USE ELASTIC STAYS | NCMDR | | mdprc 092 09 18 000 | Saudi Mais for Medical Products | Sterile single use Laryngeal Mask Airway | NCMDR | | mdprc 083 09 18 000 | Abbott | Alinity i Processing Module | NCMDR | | mdprc 082 09 18 000 | C R Bard Inc. | HICKMAN Central Venous Catheter | 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 078 09 18 000 | Sysmex Europe GmbH. | Automated Hematology Analyser XN-Series | Swissmedic | | mdprc 077 09 18 000 | I2A - Intelligence Artificielle Applications SA | SIRscan discs Amoxicillin 2 μg + clavulanic acid 1 μg | Swissmedic | | mdprc 046 09 18 000 | Degania Silicone, Ltd | Mon-a-Therm Foley catheters with temperature sensors | Swissmedic | | mdprc 045 09 18 000 | Medtronic SA | HeartWare Ventricular Assist Device Controllers | Swissmedic | | mdprc 044 09 18 000 | BioFire Diagnostics Inc | FilmArray Blood Culture Identification Panel-BCID | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 088 09 18 000 | Abbott Laboratories | ARCHITECT ICT Modules | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01256-1 | | mdprc 087 09 18 000 | Baxter Healthcare | AK 98 Hemodialysis Devices | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01233-1 | | mdprc 086 09 18 000 | Leica | BOND Slide Labeller Zebra Printer Power Supply Unit (PSU) for use with BOND-lll and BOND-MAX instruments. | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01254-1 | | mdprc 085 09 18 000 | Samsung Electronics | Samsung Digital X-Ray System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00982-1 | | mdprc 084 09 18 000 | Siemens Healthcare Diagnostics | ADVIA Chemistry Creatine Kinase (CK_L) System Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01271-1 |
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 18 000 | Vascular Technology, Inc. | VTI 8 MHz Surgical Doppler | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165673 | | mdprc 097 09 18 000 | Sysmex America Inc (N/A) | Sysmex Fluorocell PLT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166208 | | mdprc 096 09 18 000 | Medline Industries Inc. | Medline 0.9 Sodium Chloride Injection | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166187 | | mdprc 095 09 18 000 | DePuy International Limited | P.F.C. SIGMA Revision Knee System Distal Augment | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166108 | | mdprc 063 09 18 000 | C R Bard Inc | Urine Collection BARD Midstream Catch Kit with Funnel Connector | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165908 |
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