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

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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FC 700 FETAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Navigated XIA 4.5 Polyaxial Screwdriver

    FDA 510(k)
    FDA Class 2 ·Neurology

    OPERATING CYSTOSCOPE-URETHROSCOPE

    FDA Adverse Event
    Death ·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Other ·PEAK SURGICAL INC.·Product code GEI·December 9, 2010

    ASR ACETABULAR CUPS 62

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 5, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 18, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021