5 results
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16ms
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Sources: EU EUDAMED, US FDA
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
FDA Enforcement
Class II
·Terminated·Advanced Bionics, LLC·April 10, 2019
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
FDA Enforcement
Class II
·Terminated·Advanced Bionics, LLC·April 10, 2019
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
FDA Enforcement
Class II
·Terminated·Advanced Bionics, LLC·April 10, 2019
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
FDA Enforcement
Class II
·Terminated·Advanced Bionics, LLC·May 27, 2020
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
FDA Enforcement
Class II
·Terminated·Advanced Bionics, LLC·May 27, 2020