BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MST-1050-II X-RAY UNIT

    FDA 510(k)
    FDA Class 1 ·Pathology

    Legacy™3 Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307101994·Ø3.2 x 10 Platform 3.0mmD

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196594·Revision Knee Spiral Reamer- Hudson Short Flute...

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746046742·WIRE SS LOWER 016 X 016 FORM I 10/PK

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209116713·KIT, M-FAK-MTC - CUSTOM

    MAYFIELD SCANMATE MOBILE CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Defibrillator Analyzer Variable Load

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEGACY 3 IMPLANT

    FDA Adverse Event
    Malfunction ·IMPLANT DIRECT SYBRON MANUFACTURING LLC·Product code DZE·August 21, 2018

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 6, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 2010

    WALLFLEX¿ COLONIC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MQR·November 30, 2012

    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019