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

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    DIGITAL ELECTROCARDIOGRAPHS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    980 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

    DISPOSABLE PACING CABLES

    FDA Adverse Event
    Malfunction ·REMINGTON MEDICAL, INC.·Product code DSA·December 6, 2013

    FLEXI-LITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

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

    UNKNOWN DEPUY SIZE 3 FB SIGMA TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 1, 2014

    HUDSON VOLDYNE 500 VOLUMETRIC EXERCISER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BWF·May 23, 2013

    VITA 2 DDDR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 2011

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 15, 2023

    PS TIBIAL INSERTS SZ 3, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 15, 2023

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017