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

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    CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Orthopantomograph OP300

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X3 TRIATHLON CS INSERT #3 9MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2014

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012

    TRIDENT CONSTRAINED INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWZ·June 23, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022