8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707066286·KOBAYASHI PREFORMED WIRE 014"
WILSON SPINAL FRAME
FDA 510(k)
FDA Class 1
·Orthopedic
Hospira Extension Set, Hospira Primary Set
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 7, 2010
PELVILACE TO BIOURETHAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·December 3, 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