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    TRACE ELEMENTS SERUM TOXICOLOGY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BrackFix

    FDA 510(k)
    FDA Class 2 ·Dental

    DISCOVERY MR450

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLEUR-EVAC THORACIC TROCAR CATHETER 20FR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GCD·October 19, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 21, 2012

    GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa MR750 System are similar to those for the Signa HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·August 13, 2013

    GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 9, 2013