7 results
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30ms
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Sources: EU EUDAMED, US FDA
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
FDA 510(k)
FDA Class 2
·Cardiovascular
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Peralta Stone Removal Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAMITRODE 4
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 4, 2014
EZ-PRO R4 AMBUL COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV·Product code FPO·October 27, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 31, 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