BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    DSL 7900 ACTIVE DHEA-S (DSL #7900)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FLUID THIOGLYCOLLATE MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TREVAIR CHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 24, 2014

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·November 4, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2012

    36MM HUMERAL LINER +0 UNCONSTRAINED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·December 15, 2023

    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