BEUDAMED
    7 results · 32ms · Sources: EU EUDAMED, US FDA

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    T4 CLASP-BEAD EIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CLEANSER, ROOT CANAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TALENT AAA

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 24, 2014

    ADVIA CENTAUR XP HBSAG ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·January 2, 2013

    OPTETRAK

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code JWH·November 3, 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