8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUILL CATHETER GUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
36M - Kentucky Utilities
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233031·Kentucky Utilities - 36 Metal
FEMORAL ACCESS VENOUS CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
EXPORT ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 20, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·November 7, 2012
ENDOPATH ETS45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 30, 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