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

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    NEODENT IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIONEER PLUS CATHETER, MODEL PLUS 120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    INSULIN INFUSION PUMP

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

    OT VERIO IQ METER

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

    LEVEEN NEEDLE ELECTRODE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code GEI·June 27, 2011

    TRANS-RAY PLUS 7.5 FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DSP·July 17, 2017

    BD¿ NEXIVA SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019

    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