BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    GE QUASAR NUCLEAR MEDICINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TARGET ADAPTER T2 SCN

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 2, 2020

    LEGEND FOOTED ATTACHMENT

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·December 13, 2010

    MITEK VAPR PREMIERE 90 DEGREE SUCTION ELECTRODE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GEI·January 18, 2013

    AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code PAH·July 9, 2014

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

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

    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