BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    GESCO DUAL LUMEN UMBILICATH II-DL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    V-TREND TARGET IM TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSTART

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·October 2, 2023

    COBAS 8000 COBAS C 502 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 8, 2026

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2010

    UNKNOWN REJUVENATE STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 27, 2012

    HEARTMATE II LVAS

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·May 15, 2014

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020