BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    URINE SAMPLE COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Pathology

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517117632·Helix-T Clip, 2mm Green Std Tang

    Phonak

    FDA UDI
    Phonak AG·07613275472552·Lyric3 (XXL)

    VORTEK URETERAL DOUBLE LOOP STENT

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

    IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 6, 2014

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·October 10, 2012

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 2, 2010

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 3, 2012

    ACCOLADE SR SL MRI (Model L310)

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