13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ROWE SHOULDER INSTR. FOR BANKHART REPAIR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788203440·Rod Locker
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 25, 2011
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
FDA 510(k)
FDA Class 2
·Radiology
RPX TITANIUM CEMNT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·January 23, 2012
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·January 23, 2012
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·November 6, 2012
OPTA PRO PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code LIT·August 30, 2010
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·November 8, 2017
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 31, 2016
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012