8 results · 26ms · Sources: EU EUDAMED, US FDA

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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