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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    DTX-200 BONE DENSITOMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    MODEL LS 860, CO2 LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AXIOM LUMINOS DRF

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OWB·May 23, 2014

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·February 15, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·December 22, 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