13 results · 20ms · Sources: EU EUDAMED, US FDA

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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