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

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    GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MICRO TARGETING ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD ALARIS¿ SMARTSITE¿ GRAVITY SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 9, 2023

    BRIGHTVIEW X

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code KPS·January 24, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·December 14, 2010

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 14, 2014

    BD GEM V/NV 20D 0.2 FLTR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·July 28, 2022

    GEM V/NV NTG 20DP 20PK

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 10, 2020

    BD ALARIS¿ SMARTSITE¿ GRAVITY SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 20, 2023

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Enforcement
    Class I ·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021

    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