BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Fluorescence Mode

    FDA 510(k)
    FDA Class 2 ·Dental

    HEMOCHRON SIGNATURE ELITE

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016

    TI OCCIPITAL PLATE LATERAL WEDGE/60MM WIDTH

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·February 21, 2013

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code JWH·January 6, 2011

    UNK HA DERMAL FILLER

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·July 8, 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