BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELECTROTHERM MODEL HT-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Silicone Peripherally Inserted Central Venous Catheter Set/Tray

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OSCILLATING SAW ATTACHMENT II

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code GFA·June 13, 2014

    STRATA 2 VALVE, REGULAR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·December 11, 2012

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 26, 2015

    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