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

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    VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I

    EUROIMMUN ANTI-SLA/LP ELISA(LGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO TRIATHLON TS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZIMMER AIR DERMATOME II HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·October 9, 2014

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·April 24, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 15, 2011

    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