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    213 results · 17ms · Sources: EU EUDAMED, US FDA

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    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

    FDA Recall
    Terminated ·Critical Diagnostics·Product code OYG·February 28, 2012

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021