BEUDAMED
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    TRABECULAR METAL VERTEBRAL BODY REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYNTHES LCP PROXIMAL TIBIA PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·April 12, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·May 22, 2008

    BD INSYTE

    FDA Adverse Event
    Injury ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 28, 2025

    4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal 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 Signa HDe system reflect the spatial distribution of protons (hydrogen 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·November 9, 2010