BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UC IMU B

    FDA 510(k)
    FDA Class 2 ·Immunology

    JUPITER PROCESSING AND REVIEW WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN DEPUY METAL FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·January 22, 2013

    PIROUET

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    BD SAFETYGLIDE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·January 28, 2024

    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