11 results
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20ms
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Sources: EU EUDAMED, US FDA
AUSTIN MOORE HALLOW CHISEL
FDA 510(k)
FDA Class 1
·Orthopedic
INTER FIX™ Threaded Fusion Device
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978072104·16X23MM INTER FIX THREADED
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·January 15, 2025
ALARA Neuro Access Kit
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
FDA 510(k)
FDA Class 2
·Cardiovascular
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 29, 2010
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
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