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

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    RESUBMITTED EXCALIBUR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FEM. MODULAR HEAD

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code LZO·August 5, 2019

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256570·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256617·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256587·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256556·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256600·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256549·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256563·Articulating Surfaces, CCK

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575256594·Articulating Surfaces, CCK

    INREACH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAVIO™ Surgical System (NAVIO system)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TAH BSO MONARCH SLING

    FDA Adverse Event
    Injury ·Product code OTN·June 13, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 22, 2010

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·December 19, 2012

    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    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

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

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