BEUDAMED
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    DIRECT IRON REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ERA® Implant Abutment Micro 0°, 5mm Cuff (AL)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549104527·Implant retained overdentures are an establishe...

    ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SOL-M EXCHANGEABLE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REALSEAL

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·May 15, 2014

    SUBQ

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·October 31, 2012

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Other ·INSULET CORPORATION·Product code LZG·August 19, 2010

    GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 17, 2013

    GE Healthcare Infinia Hawkeye 4 Option 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 I ·Terminated·GE Healthcare, LLC·July 31, 2013

    GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option 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·November 19, 2014

    GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025