BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    OSTEO-MESH TM-300

    FDA 510(k)
    FDA Class 2 ·Dental

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984230·anteriors; shade B1; mould R 51

    AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)

    FDA 510(k)
    FDA Class 2 ·Radiology

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 10, 2011

    SYNERGY

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·August 6, 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