BEUDAMED
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    CryoThin™ Surgical System and Accessories

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

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101162·DLEK CORNEAL DISSECTOR, VAULTED

    5M MEDICAL FLAT PANEL DISPLAY, ME511L

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFUSION SYRINGE SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 14, 2008

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 22, 2011

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·July 12, 2013

    RENAISSANCE SYSTEM

    FDA Adverse Event
    Injury ·MAZOR ROBOTICS LTD·Product code HAW·February 28, 2022

    Revogene, Catalog no. 610210. IVD test instrument

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