BEUDAMED
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    LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    APC anti-human CD11b

    FDA UDI
    BIOLEGEND, INC.·00810034701039·URL: https://www.biolegend.com/en-us/products/a...

    VIZTEK DR, MODELS: DR1000, DR3000, DR4000

    FDA 510(k)
    FDA Class 2 ·Radiology

    New Era

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 23, 2014

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 28, 2013

    ARCHITECT TOTAL PSA

    FDA Adverse Event
    Injury ·ABBOTT LABORATORIES·Product code LTJ·February 9, 2011

    2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010