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

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    ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pentair

    FDA UDI
    PENTAIR FILTRATION SOLUTIONS, LLC·B46211312495·

    MODIFICATION TO STRYKER PAINPUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERIGAGE MODEL 1243RA, 1243RB, 1243RE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIM400 IMPLANT MAGNET

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 19, 2017

    INFINION? CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 18, 2025

    COCHLEAR BAHA ATTACT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 26, 2016

    ATTRACT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 15, 2015

    COCHLEAR BAHA ATTACT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016

    BIM400 IMPLANT MAGNET

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016

    SP MAGNET 3

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 13, 2016

    COCHLEAR BAHA ATTRACT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 14, 2016

    BIM400 IMPLANT MAGNET

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 8, 2025

    HUDSON VENTILATOR TUBING SET, NOVATION

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·May 23, 2013

    PARADIGM REAL -TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

    COCHLEAR BAHA ATTACT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 10, 2016

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016