7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RMI CAROTID BY-PASS SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
Biopor, AOC Porous Polyethylene, Cerepor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TOTAL AND HEMI SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
MAXIMO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NIK·October 7, 2010
RELIANCE SYNERGY WASHER
FDA Adverse Event
STERIS CANADA CORPORATION·Product code LDS·December 6, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012