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

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    HEMATOLOGY DATA MANAGEMENT SYS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONE-TROL HEMOGLOBIN A1C CONTROL SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IQ NASAL MASK, MODEL 50160 REV. D

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PHYSIOMESH OVAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·May 20, 2014

    UNKNOWN RIGHT REJUVENATE/ABGII HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 24, 2012

    TRUERESULT

    FDA Adverse Event
    Malfunction ·HOME DIAGNOSTICS, INC.·Product code NBW·April 15, 2015

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012