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

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    PREPARE LOCK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PROTECTRODE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUKUSLEEVE

    FDA 510(k)
    FDA Class 1 ·Dental

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·January 30, 2013

    ENDOPATH** XCEL*

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·December 22, 2010

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 15, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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