BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    ZERO-G(TM) GEL/FOAM MATTRESS TOPPER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    GENZYME DIRECT-AMYLASE TEST REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 1, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·January 11, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·July 3, 2014

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015