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

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    ORALCHEK SUPER-SOFT BRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    ATLANTIS HYPERBARIC CHAMBER VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HIVOX Spopad EMS SP-911, SP-921

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    WEBSTER QUADROPOLAR - FIXED

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 26, 2012

    NOVASILK FLAT SQUARE MESH

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTO·June 24, 2014

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·November 2, 2010

    LAMITRODE S8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 2012

    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