BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MEDI GUARD SHEETS/UNDERLAYS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NAUTILUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KINETIX PTCA GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·December 1, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 3, 2014

    3) Signa Advantage (K911959 Signa Advantage 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