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

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    REFLEX(R) ECA

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LACERATION TRAY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POLY INSERT 20 DEGREE

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CADD LEGACY PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FRN·April 6, 2021

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 22, 2013

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·December 8, 2010

    VPAP S SUB-ASSY-AMERICAS

    FDA Adverse Event
    Death ·RESMED LTD·Product code BZD·July 1, 2014

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code NPT·December 21, 2018

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017