BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LOGIQ 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 20, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·October 31, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 4, 2015

    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