BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    KOTEX STICK TAMPONS, REGULAR AND SUPER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709082·GC Initial™ PC Pellets Bleached AO+, 5pcs. X 2

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228720181·GC Initial™ PC Pellets Bleached AO+, 5pcs. X 2

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376680668·Proximity Drill, 18mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867311763·Low Profile Screw, 2.0 x 18mm, Cortical

    LEADS, IMPLANTABLE CARDIAC PACEMAKERS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BS-200 CHEMISTRY ANALYZER, MODE BS-200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 18, 2018

    LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·August 8, 2025

    LOW PROFILE SCREW, 2.0 X 20MM, CORTICAL

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·August 8, 2025

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 13, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 14, 2010

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MFG·Product code FJI·December 11, 2012

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024