BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Neurology

    SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VRESELECT CULTURE MEDIUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OPTICROSS HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 30, 2023

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 17, 2013

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 25, 2008

    OPTICROSS? HD

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025

    OPTICROSS? HD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018