BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    ELECTROENCEPHALOGRAPH

    FDA 510(k)
    FDA Class 2 ·Neurology

    AEON-C™ Stand Alone System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·November 7, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2015

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020