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

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    KLEIN MICRO-CANNULA HANDLE(TM)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Q-LUX PLASMA 100 LIGHT CURE UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    NEOSALUS LOTION

    FDA 510(k)
    FDA Unclassified ·Unknown

    DIACAM (510(K) K 901019)

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 5, 2014

    LCS ROT PATELLA LG+

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·January 8, 2013

    SIGMA 300 DR

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code DXY·November 17, 2010

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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