BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777457·LUMBAMED PLUS FLEX PAD WM SILVER III

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450459287·

    SYNTHES STERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIQ E9

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    SURGICAL MESH FOR PELVIC PROLAPSE

    FDA Adverse Event
    Injury ·Product code FTL·October 23, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·July 8, 2013

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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