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

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    THERATHERM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MINI LAP INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    2800

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

    ACCU-CHEK AVIVA TEST STRIPS

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

    MIC GASTROSTOMY FEEDING TUBE

    FDA Adverse Event
    Injury ·BALLARD MEDICAL PRODUCTS·Product code KNT·June 13, 2007

    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