BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    Cranial Reducing Tubes

    FDA 510(k)
    FDA Class 2 ·Neurology

    RAPIDTEG TEG-ACT TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HWC·October 28, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·February 14, 2013

    PURITAN BENNETT VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code BTM·January 11, 2011

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JDI·July 15, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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