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

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    ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM 70 AND 100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ROCHE REAGENT FOR GGT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·February 11, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 10, 2011

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 24, 2014

    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