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

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    T-3 RIA REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COLORISE

    FDA 510(k)
    FDA Class 2 ·Dental

    Neurovision Nerve Locator Monitor (Nerveana), EMGView Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 18, 2014

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 29, 2007

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 3, 2012

    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

    ACCOLADE SR SL MRI (Model L310)

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