BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    HEFFINGTON KNEE REST

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AcQGuide Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COAGUCHEK XS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 10, 2012

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code GJS·August 10, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020