9 results
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17ms
·
Sources: EU EUDAMED, US FDA
TEMPORARY ATRIAL ELECTRODE KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Ceramill PEEK by JUVORA™ Oyster White
FDA UDI
JUVORA LIMITED·05055948229308·CERAMILL PEEK by JUVORA™ 760403, Oyster White 9...
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471179444·Anatomical Molar Bands, Lower Right 1St Molars,...
SmartStart Air/Water and Suction Valves
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PTA (PROGRESSIVE TIBIAL ALIGNMENT)
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL·Product code KXA·September 26, 2012
MARATHON MICRO CATHETER
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code KRA·July 8, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014