BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    I-DHEA-SULFATE RIA KIT 125

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCOMMODATOR WHEELCHAIR, MODEL #2000X

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEXUS AND NXT DETACHABLE COIL

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code HCG·January 16, 2009

    PERI-GUARD PERICARDIUM WITH APEX PROCESSING

    FDA Adverse Event
    Injury ·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·May 20, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 25, 2012

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code KNW·August 9, 2007

    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