BEUDAMED
    7 results · 32ms · Sources: EU EUDAMED, US FDA

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    SHELHIGH PERICARDIAL PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARGILITE 3

    FDA 510(k)
    FDA Class 2 ·Dental

    HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 4, 2015

    SINGLE USE INJECTOR

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FCG·May 23, 2014

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DXY·February 15, 2013

    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