BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    HIP FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGISEAL Topical Skin Adhesvie

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CENTRION 500 C-ARM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH LTD. / HUNTINGTON·Product code HQL·June 13, 2014

    ARCHITECT ANTI-HBS

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code LOM·February 8, 2013

    URETHRAL SLING

    FDA Adverse Event
    Injury ·Product code FTL·January 3, 2011

    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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