13 results
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25ms
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Sources: EU EUDAMED, US FDA
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188551·Integra® Jarit® Hibbs Gouge, 9-1/2", Straight, ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117551·Distal Reamer (Hudson)
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127857·Distal Reamer (Hudson)
Analog
FDA UDI
BICON, LLC·00813110025166·5.0mm Stealth Abutment Analog
The Happy Gilmore Bushing
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215096052·
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 22, 2002
Mont Blanc Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
POWERHOHN AND POWERLINE CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 14, 2014
CRE BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 15, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013