BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517630551·CoRoent Ant TLIF Ti, 13x11x40mm 15°

    OMNI Mod Hip

    FDA UDI
    Omni Life Science, Inc.·00841690103028·Modular Neck 13 degree Anteversion, Medium 42.5

    K231485

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·October 25, 2025

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164658·BLACKHAWK,STERILE,CONVEX,14X12X5

    IFUSE IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LabPro Data Management System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025