8 results
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37ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
FDA Enforcement
Class II
·Terminated·Cochlear Americas Inc.·January 15, 2020