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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 103 02 12 | MATHYS | Bone graft substitute, cyclOS Putty | BfArM | | mdprc 102 02 12 | Waters Corp | Laboratory, Masstrak Immunosuppressants XE RUO Kit | BfArM | | mdprc 101 02 12 | Siemens Medical Solutions | IVDs, IMMULITE CK-MB | BfArM | | mdprc 100 02 12 | bioMerieux Inc | IVDs, ATB ANA EU Kit | BfArM | | mdprc 099 02 12 | Aesculap | Sterile Procedure Sets, SUSI Instruments | BfArM |
MDCO
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 144 02 12 | BD Diagnostic Systems | BD PrepStain Vacuum Pumps | http://www.mdco.gov.hk/english/recalls/recalls_20120213.html | | mdprc 057 02 12 | 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 | 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 |
|---|
| mdprc 157 02 12 | Vascutek Limited | Implants, non active, end prostheses for aortic aneurysms, Anaconda and Anaconda ONE-LOK stent graft systems. | MHRA | | mdprc 156 02 12 | ThermoFisher Scientific | IVDs, bacteriology, Oxoid ready poured plate, CLED agar | MHRA | | mdprc 155 02 12 | The Helping Hand Company | Hoists, electrical mobile base unit, Skyframe turntable | MHRA | | mdprc 154 02 12 | Ropox A/S | Shower aids, Ropox Hudson shower bed | MHRA | | mdprc 153 02 12 | Intuitive Surgical Inc | Endoscopes, rigid accessories, Da Vinci S surgical system, Da Vinci Si surgical system, and Da Vinci Si-e surgical system | MHRA |
NCAR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 084 02 12 | Cook Medical | In vitro fertilization culture medium kit | NCAR | | mdprc 109 01 12 | Leica Microsystems Inc. | Ophthalmic surgical microscope | NCAR | | mdprc 078 12 11 | Medion Grifols Diagnostics AG | Antibody identification cell panel kit | NCAR | | mdprc 056 12 11 | Smith & Nephew inc | Bone Screws, TRIGEN INTERTAN Intertrochanteric Nails | NCAR | | mdprc 055 12 11 | Philips Medical Systems | Radiographic unit, mammographic | NCAR |
NCMDR
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 121 02 12 | Varian Medical Systems | Varian Clinac® accelerators with Mark or Millennium MLC and BrainLAB m3 MLC | NCMDR | | mdprc 120 02 12 | Philips Healthcare | Computed Tomography, Brilliance Workspace Portal | NCMDR | | mdprc 085 02 12 | Philips Healthcare | IntelliVue Patient Monitors | NCMDR | | mdprc 054 02 12 | Accuray Inc | Radiology, Treatment, MultiPlan® Treatment Planning System | NCMDR | | mdprc 108 01 12 | Stryker Orthopaedics | Implants, Knee. Scorpio Tibial Punch Tower | NCMDR |
Swissmedic
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 150 02 12 | Codman | Cranium, Neurosurgical procedures, Codman ICP Skull Bolt Kit | Swissmedic | | mdprc 149 02 12 | Roche Diagnostics Corp | IVDs, cobas c-pack MULTI | Swissmedic | | mdprc 146 02 12 | Balt Extrusion | BALTACCI Infusion Catheters | Swissmedic | | mdprc 145 02 12 | Hamilton Medical Inc | Ventilator, HAMILTON-G5/S1 | Swissmedic | | mdprc 055 02 12 | Newdeal SAS | Implantation, Advansys Medical Lisfranc Plates | Swissmedic |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 164 02 12 | Varian Medical Systems | 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106591 | | mdprc 163 02 12 | Newport Medical Instruments Inc | Ventilator. Cable, an accessory to the Newport HT50 ventilator | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103824 | | mdprc 162 02 12 | Life Recovery Systems HD | Monitoring of patient temperature, Thermosuit | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106096 | | mdprc 161 02 12 | GE Healthcare | Imaging, Transfer, Table. GE SIGNA EXCITE MR SURGICAL OPTION | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106393 | | mdprc 160 02 12 | Elekta Inc | Radiation therapy treatment, Elekta Synergy Imaging System | http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107177 |
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