BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44

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

    SNAP M. TUBERCULOSIS COMPLEX

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PROMUS ELEMENT ¿ LONG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 9, 2013

    LEAD EXTENSION

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NIK·July 1, 2014

    TO GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·July 27, 2021

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024