BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    COBRA HAND PIECE

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

    LateralALIF

    FDA UDI
    Nuvasive, Inc.·00887517839954·ALIF Access Retractor Frame, 12" Half

    NicoletOne

    FDA 510(k)
    FDA Class 2 ·Neurology

    TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRILOGY 100

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

    RIATA PASSIVE FIXATION

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

    ARTHROSCOPE

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·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