BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    TME Temporary Myocardial Electrode

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Trellis Reserve Infusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code NBW·October 14, 2004

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 5, 2023

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·November 13, 2008

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·August 18, 2011

    FOLEY CATHETER, 16F

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, INC.·Product code NWR·July 9, 2013

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025