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

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    MOSAIC 3D (Surgical Laser)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364810·IdentiTi ALIF SA, Awl, Angled, 40°

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364827·IdentiTi ALIF SA, Awl, Angled, 60°

    VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DXL CALSCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    TRIDENT ALUMINA INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·July 18, 2013

    STELLARIS PC VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·November 18, 2015

    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