BEUDAMED
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    AX WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Helix Genetic Health Risk App for late-onset Alzheimer’s disease

    FDA 510(k)
    FDA Class 2 ·Immunology

    MONOPOLY PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN DEPUY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 7, 2013

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·August 8, 2014

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013