BEUDAMED
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    VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CONSEPSIS(TM)

    FDA 510(k)
    FDA Class 2 ·Dental

    BELTONE PROFILE IN-THE-EAR HEARING AID

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

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 29, 2014

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021