BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    PLEURA-GARD ATS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PACEMAKER, MODEL 251-01

    FDA 510(k)

    SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    S-ROM M HEAD 36MM +3

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code JDI·June 13, 2014

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010

    DESARA SLING

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·December 7, 2012

    Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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