BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    QUANTA LITE IGA ACA (HRP)

    FDA 510(k)
    FDA Class 2 ·Immunology

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221116864·3M™ Victory Series™ First Molar Bands, 953-366,...

    T2 - NAIL HOLDING SCREW, TIBIA 10 MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·May 21, 2025

    T2 - NAIL HOLDING SCREW, TIBIA 10 MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·June 23, 2025

    LOGIQ Fortis

    FDA 510(k)
    FDA Class 2 ·Radiology

    NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·July 30, 2015

    CAPSURE FIX NOVOUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·July 23, 2014

    T2 - NAIL HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·May 21, 2025

    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