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

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    Vitrea CT Brain Perfusion

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 16, 2022

    CRANIAL REMOLDING ORTHOSIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    TM-400

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 14, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·July 22, 2011

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021

    KIT BD MAX ENTERIC VIRAL PANEL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024