BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345027244·Inserter, 11-16MM, Lumbar Straight

    GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOLIS 12I

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code GZB·May 6, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    INTROCAN SAFETY

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FOZ·May 28, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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