8 results
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26ms
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Sources: EU EUDAMED, US FDA
LARYNGOSCOPES RIGID
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788225250·Cervical Rasp 6x14x12, 12 deg Lordotic
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROTALINK? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·May 21, 2014
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 7, 2012
OPTI-FREE REPLENISH
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATIES, INC.·Product code LPN·August 27, 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