BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    PARA 12

    FDA 510(k)
    FDA Class 2 ·Hematology

    BP652N (HEM-6300-Z)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2014

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 5, 2012

    KENDALL

    FDA Adverse Event
    Malfunction ·KENDALL - COVIDIEN·Product code FMI·August 27, 2010

    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