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

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    ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMFORTGEL NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE-TEX VASCULAR GRAFT

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·June 2, 2021

    GORE-TEX VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·June 10, 2021

    COPIOS PERICARDIUM MEMBRANE

    FDA Adverse Event
    Injury ·Product code NPL·June 10, 2020

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021