BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    TEEN 100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CORVAC BLOOD COLLECTION TUBE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MIDDLE EAR ANALYZER, MODEL AE-803

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

    PELORIS RAPID TISSUE PROCESSOR

    FDA Adverse Event
    Malfunction ·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·December 16, 2010

    ENDURANT II

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·July 18, 2014

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 26, 2012

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015