BEUDAMED
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    PRISMA DISPOSABLE SILICONE BULB

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYVA ADVANCE EMIT PHENYTOIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·June 2, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 17, 2012

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIV.·Product code FNL·October 13, 2010

    Discover VH/Millennium VG Nuclear Medicine Imaging System

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·January 16, 2019

    GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015

    GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 19, 2014

    GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 19, 2014