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

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    INTERACOUSTICS CLINICAL AUDIOMETER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    INFINITY PLUS ELECTROTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Wrist Hemiarthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOVIVE¿ ONE STEP BUTTON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KGC·February 4, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·December 23, 2010

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·July 17, 2014

    NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER MANUFACTURING B.V.·Product code JWH·December 23, 2025

    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