BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    KNIFE BLADE TIP

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Lumen 155-SF

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SENOMARK ULTRA BREAST TISSUE MARKER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OXF UNI TIBIAL TRAY SZ C LM PMA

    FDA Adverse Event
    Injury ·BIOMET U.K. LTD·Product code NRA·May 21, 2014

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·October 29, 2012

    WECK AUTO ENDO5 ML

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GEF·June 8, 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