BEUDAMED
    10 results · 34ms · Sources: EU EUDAMED, US FDA

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    HOWMEDICA FULLY THREADED SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MARIONETTE SA, MODEL 001 001 & 001 002

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EsophyX Z, EsophyX2 HD

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MITEK EXPRESSEW III NEEDLE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·February 21, 2013

    TRIMA ACCEL (PLT)

    FDA Adverse Event
    Other ·CARIDIANBCT·Product code GKT·January 14, 2011

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 25, 2014

    RADIOLUCENT INSERTION HANDLE FRN

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·January 5, 2022

    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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