BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    SENSITITRE STABILITY PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Invenia ABUS Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

    PREMICRON GREEN 1 (4) 75CM DS30 (M)

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAT·May 28, 2014

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 25, 2010

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 19, 2012

    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. 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