BEUDAMED
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    PANA SPRAY Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    BIO-CLAD ALL POLY CUP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304256002·

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221046666·Unitek(TM) Molar Band General Purpose Wide Hard...

    INGENUITY TF PET/MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEN TEK NIGHTGUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·June 11, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 15, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 19, 2008

    Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code OUO·April 13, 2012