BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    PERIFIX PEDIATRIC EPIDURAL KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DRILL SLEEVE F. SOLID STEPDRILL

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·February 23, 2012

    SURGISIS, SURGISIS ES

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

    Kuschall Advance Manual Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·February 14, 2013

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV·Product code LGW·January 13, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·July 29, 2014

    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