7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STACLOT PROTEIN C TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
FDA 510(k)
FDA Unclassified
·Unknown
FLEXIBLE TIP ASPIRATING TUBES
FDA 510(k)
FDA Class 2
·General Hospital
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODUALTION·Product code LGW·December 4, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012