BEUDAMED
    21 results · 55ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    COCHLEAR NUCLEUS CI512

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS INC.·Product code MCM·May 29, 2014

    COCHLEAR NUCLEUS CI512

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·May 29, 2014

    COCHLEAR NUCLEUS FREEDOM

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·October 30, 2014

    NUCLEUS

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·June 11, 2012

    COCHLEAR NUCLEUS W/CONTOUR ADVANCED

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·March 17, 2013

    NUCLEUS CI512

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS INC.·Product code MCM·February 10, 2013

    NUCLEUS #5

    FDA Adverse Event
    Other ·COCHLEAR AMERICAS, INC.·Product code MCM·August 1, 2014

    NUCLEUS 5 WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS INC·Product code MCM·December 23, 2011

    NUCLEUS

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS INC·Product code MCM·December 23, 2011

    NUCLEUS CI512

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·August 11, 2013

    NUCLEUS 5

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·August 11, 2013

    COCHLEAR NUCLEUS CI512

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·December 9, 2015

    COCHLEAR NUCLEUS CI512

    FDA Adverse Event
    Malfunction ·COCHLEAR AMERICAS, INC.·Product code MCM·December 4, 2015

    Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code MCM·September 16, 2011

    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code MCM·June 5, 2015

    Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code MCM·September 30, 2009

    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code LXB·December 18, 2018

    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

    FDA Recall
    Terminated ·Cochlear Americas Inc.·Product code LXB·April 9, 2014

    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.

    FDA Enforcement
    Class II ·Terminated·Cochlear Americas Inc.·June 11, 2014

    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes

    FDA Enforcement
    Class II ·Terminated·Cochlear Americas Inc.·July 29, 2015