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

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    EMIT 2000 PROCAINAMIDE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 26, 2019

    RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GEA·December 27, 2018

    SPACELABS ULTRAVIEW PATIENT MONITOR

    FDA Adverse Event
    Death ·SPACELABS HEALTHCARE INC.·Product code MHX·June 20, 2014

    SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·January 18, 2013

    HEATING PAD

    FDA Adverse Event
    Injury ·UNKNOWN·Product code IRT·October 13, 2010

    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