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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NEURO II-SE, MODELS: OR-DR-OR, OR-MB

    FDA 510(k)
    FDA Class 2 ·Radiology

    EON Portable Reverse Osmosis Water Purification System

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

    G7 NEU +5MM E1 LINER 40MM I

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 10, 2021

    CUSA EXCEL CONSOLE 110V AC WITH FOOTSWITCH

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·February 1, 2013

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·January 26, 2011

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 31, 2014

    CER BIOLOXD OPTION HD 40MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·March 8, 2021

    AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses

    FDA Recall
    Terminated ·Marietta Vision·Product code LPN·February 21, 2011

    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