BEUDAMED
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    KEELER VANTAGE INDIRECT OPHTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150713·K-WIRE - SINGLE TROCAR 1.0mm DIA x 100mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm

    ID-RING

    FDA UDI
    DiaDent Group International·08806383525572·Used for color coding files

    NANOFUSE DBM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMERICAN BANTEX, MODEL MS 3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code BTS·March 4, 2014

    HT50 VENTILATOR

    FDA Adverse Event
    Malfunction ·FLIGHT MEDICAL·Product code CBK·December 17, 2010

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·December 27, 2012

    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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026