BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Summit DuoFix HA Coating

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reveal

    FDA UDI
    Oticon A/S·05707131341372·G20, BTE 13 PP 2.4G 105 C093 REVEAL

    DR. SCHOLL'S COMPRESSION SOCKS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEXUS TKO-6, LUER-ACTIVATED DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2024

    MIRU 1DAY UPSIDE (MIDAFILCON A)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 22, 2025

    URISYS 2400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JIL·October 7, 2008

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 5, 2011

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·June 27, 2013

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·June 14, 2023

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023