8 results
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17ms
·
Sources: EU EUDAMED, US FDA
NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS
FDA 510(k)
FDA Class 2
·General Hospital
STERLING
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975064066·
NERVUS MONITOR
FDA 510(k)
FDA Class 2
·Neurology
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM·Product code FNL·April 29, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·October 31, 2012
PUMP MMT-522LNAS PRDGM INS SK EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 26, 2010
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