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

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    ROBICSEK INTRACARDIAC SUCTION WAND

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMV W/BAG #M-507

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 24, 2014

    UNKNOWN IMPLANTABLE PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·December 31, 2012

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 5, 2010

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·March 8, 2019

    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026