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

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    HANSATOME MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CosmoLock Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPEEDICATH COMPACT

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

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 14, 2015

    HME ADULT FILTERED 25/CS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code BYD·February 21, 2013

    SPECTRA OPTIA EXCHANGE SET

    FDA Adverse Event
    Other ·CARIDIANBCT·Product code LKN·January 14, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 1, 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