BEUDAMED
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    MANIPULATOR & INJECTOR, UTERINE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00840326404805·.022 U/L Std. Comb. Weld Size#27

    VariAx 2 Compression Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVIA CHEMISTRY ENZYMATIC CREATININE_2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·October 3, 2012

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code OUT·April 24, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·July 27, 2010

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014

    ACCOLADE SR SL MRI (Model L310)

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