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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEQUENTIAL PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    iChemVELOCITY Automated Urine Chemistry System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD CONNECTA¿ STOPCOCKS

    FDA Adverse Event
    Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·June 30, 2016

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCUALR, LLC·Product code GEI·February 15, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 26, 2011

    ECHELON LINEAR CUTTER RELOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2014

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·April 21, 2025

    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