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

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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257128466·30-40 MV FOR MEN SEL EW CLF STD GREY III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257129944·30-40 MV FOR MEN CLSC EW STD GREY III

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 16, 2023

    EQUALIZER OCCLUSION BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LYPHOCHEK ASSAYED CHEMISTRY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 9, 2011

    QUICKIE Q7

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC.·Product code IOR·July 18, 2013

    PFNA BLADE PERF L105 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HSB·January 26, 2015

    BIHAPRO SHELL HA/PC 52MM LN 23

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 22, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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