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

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    LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Vent-Os Sinus Dilation family

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    CAPTURE-R READY SCREEN 4

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·September 22, 2011

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 4, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 2, 2013

    BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 30, 2022