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

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    C CLAMP

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

    SUTURE WOUND TRAY MILFORD WHITTINSVILLE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 13, 2014

    ADVIA CENTAUR XP

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MOI·October 13, 2010

    4.0MM CANNULATED SCREW LONG THREAD/46MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·December 13, 2012

    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