BEUDAMED
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    NuVasive Brigade Lateral System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIGILANT EEG MONITOR MODEL VIGILANT 2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    LOFRIC PRIMO MALE CH12

    FDA Adverse Event
    Injury ·WELLSPECT HEALTHCARE·Product code GBM·June 14, 2013

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 21, 2011

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 24, 2008

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·July 9, 2022

    C-QUR MOSAIC

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012