BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    CareSens S Fit BT Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PLANMECA PROMAX 3D MAX

    FDA 510(k)
    FDA Class 2 ·Dental

    VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code NIK·January 13, 2014

    TRABECULAR METAL ACETABULAR SHELL

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JDI·July 14, 2011

    DELTA CERAMIC FEM HD 36/+3MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·August 18, 2023

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015