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

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    ADVANTAGE 3000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALIF

    FDA UDI
    Nuvasive, Inc.·00887517973016·ALIF Blade, 140mm Wide

    CALCIUM, SCAL, NORTROL, ABTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Gastric Sizing Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·August 5, 2015

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·August 1, 2014

    Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.

    FDA Recall
    Terminated ·McKesson Provider Technologies Medical Imaging Group·Product code DQK·January 27, 2010

    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