BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    LEAF PATIENT MONITORING SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACU-STRAP MOTION SICKNESS BAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    OCCLUSION BALLOON CATHETER MODEL OBC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOSIS,PEDICLE SPINAL FIXATION

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MNI·December 8, 2015

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 28, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·March 25, 2015

    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

    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