7 results
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26ms
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Sources: EU EUDAMED, US FDA
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
FDA 510(k)
FDA Class 2
·General Hospital
QUIK-TEMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZIMMER SKIN GRAFT MESHER CUTTER 3:1 RATIO
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·April 1, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 2, 2012
MESH - VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·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