BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    LIGHT SOURCE, ENDOSCOP, XENON ARC

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LightLas Pattern Scanning System - TruScan Pro

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EASYFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 3, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 30, 2012

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    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