BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

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

    SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GENSTRIP TEST STRIP MODEL 100-201

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 27, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 5, 2011

    CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.

    FDA Enforcement
    Class II ·Terminated·ASO, LLC·August 14, 2013