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

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    EM-V

    FDA 510(k)
    FDA Class 2 ·Hematology

    MONOSTICON TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    DualX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·April 30, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 10, 2012

    CRUCIATE RETAINING TIBIAL INSERT

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code JWH·July 28, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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