BEUDAMED
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    Biograph mCT and mCT Flow PET/CT Scanners

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837088200·

    NORWOOD ABBEY CENTURION SES EPIKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MYLABSIX ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHARGING SYSTEM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 4, 2013

    CURLIN INFUSON PAINSMART IOD IV PUMP

    FDA Adverse Event
    MOOG MEDICAL DEVICES GROUP·Product code FRN·June 23, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    DEKA MOTUS AY

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

    C-QUR MOSAIC

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

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    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