BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    OPTEO, VIDEOGRAPH HD

    FDA 510(k)
    FDA Class 2 ·Dental

    MSC LIPID CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DYNALOK CLASSIC SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 20, 2023

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 12 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 11, 2022

    BELT CLIP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·May 29, 2013

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·May 11, 2011

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    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