7 results
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18ms
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Sources: EU EUDAMED, US FDA
DISSCAP 140
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M.R. ASSOC. SNARES; CRESCENT SNARE WIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 20, 2014
ULTRALITE 680S PHOTOTHERAPY UNIT
FDA Adverse Event
Injury
·ULTRALITE ENTERPRISES INC.·Product code KGL·October 31, 2012
THERMAL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code JJE·August 26, 2010
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012