BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    SancDam Latex Oral Dam

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ITJ·January 7, 2013

    RANGE SPINAL SYSTEM (MESA AND DENALI)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYRINGE 20ML LL NS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·December 28, 2023

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 17, 2021

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ITJ·August 29, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    HELIX REVOLUTION ACP SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code KWQ·July 8, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 8, 2013

    BD PLASTIPAK¿ SYRINGES NON-STERILE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 27, 2023

    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    SYRINGE 20ML LL NS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·November 21, 2023