BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    PSI TITANIUM ANEURYSM CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    POST EXTRA SYSTOLIC POSTENTLATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    QuantX Breast MRI Biopsy Guidance Plugin

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERRAD 100S STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 8, 2006

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·February 15, 2011

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2014

    STERRAD 100NX STERILIZER 1-DR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021

    Set-Up Pack, part number PSS1305(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    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