7 results
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25ms
·
Sources: EU EUDAMED, US FDA
EUP-C321 5.0MHZ CONVEX TYPE PROBE
FDA 510(k)
FDA Class 2
·Radiology
T.E.A.R. TECH3
FDA 510(k)
FDA Class 2
·Physical Medicine
TruDi NAV Wire
FDA 510(k)
FDA Class 2
·Neurology
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 28, 2010
TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LQC·November 30, 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