BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEFLEX ACRILATO

    FDA 510(k)
    FDA Class 2 ·Dental

    TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 22, 2008

    BOSTON SCIENTIFIC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·April 21, 2008

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013

    BD CONNECTA¿ STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·May 24, 2019

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019