BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    NuVasive® XLX Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRABIS [K173893]

    FDA Adverse Event
    Injury ·COLIGNE AG·Product code PLR·April 23, 2019

    IVUE 500

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEPILEX TRANSFER AG

    FDA 510(k)
    FDA Unclassified ·Unknown

    ORIGEN BIOMEDICAL DUAL LUMEN 13FR CATHETER

    FDA Adverse Event
    Injury ·ORIGEN·Product code DWF·June 9, 2015

    VERSE CORRECTION KEY

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·February 13, 2020

    ELLIPSE VR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 15, 2014

    NEUROFORM STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code NJE·July 24, 2011

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 17, 2013

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    VERSE CORRECTION KEY

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·February 18, 2020

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025