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

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    TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COOLAN 300

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 16, 2010

    CORTEX SCREW S.T. Ø3.5X30MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HRS·July 12, 2014

    Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·May 16, 2018