BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO: COMPEL SURGICAL DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    X-RAY VVA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECSYS IGF-1

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFL·November 3, 2025

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECH CTR·Product code HQC·May 14, 2014

    UNKNOWN LEFT ABGII HIP STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code KWY·January 8, 2013

    FLASMABLADE TNA TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Other ·PEAK SURGICAL INC.·Product code GEI·November 5, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021