Cochlear Americas

FDA Filings

This page includes the latest FDA filings for Cochlear Americas. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Cochlear Americas
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments2019-11-15
Cochlear Americas
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments2019-07-03
Cochlear Americas
BA310 Abutment, BIA310 Implant/Abutment2018-12-19
Cochlear Americas
Cochlear Baha SoundArc2017-06-07

Latest Premarket Applications

PMAManufacturerDevice NameDate
Cochlear Americas
Nucleus 24 Cochlear Implant System (EA22 Stiffener)2019-10-08
Cochlear Americas
Nucleus Auditory Brainstem Implant System2019-08-27
Cochlear Americas
Nucleus 24 Cochlear Implant System2019-08-27
Cochlear Americas
Nucleus 24 Cochlear Implant Sysstem2019-07-02
Cochlear Americas
Nucleus Auditory Brainstem Implant System2019-07-02
Cochlear Americas
Nucleus ABI541 Auditory Brainstem Implant2019-06-05
Cochlear Americas
Nucleus 24 Cochlear Implant System2019-06-05
Cochlear Americas
Nucleus Hybrid Cochlear Implant System2019-06-05
Cochlear Americas
Nucleus Auditory Brainstem Implant System2019-03-08
Cochlear Americas
Nucleus 24 Cochlear Implant System2019-03-08
Cochlear Americas
Nucleus Hybrid Implant System2019-03-08
Cochlear Americas
Nucleus 24 Cochlear Implant System2018-09-10
Cochlear Americas
Nucleus Auditory Brainstem Implant System2018-09-10
Cochlear Americas
Nucleus Hybrid Implant System2018-09-10
Cochlear Americas
Nucleus C1532 Cochlear Implant2018-07-11
Cochlear Americas
Nucleus Auditory Brainstem Implant2018-06-13
Cochlear Americas
Nucleus Hybrid L24 Implant System2018-06-13
Cochlear Americas
Nucleus Cochlear Implant System2018-06-13
Cochlear Americas
Nucleus 24 Cochlear Implant System (Nucleus 7 Sound Processor)2018-05-24
Cochlear Americas
Nucleus 24 Auditory Brainstem Implant2018-05-11
Cochlear Americas
Nucleus 24 Cochlear Implant System2018-05-11
Cochlear Americas
Nucleus AB1541 Auditory Brainstem Implant2018-03-16
Cochlear Americas
Nucleus Hybrid Cochlear Implant System2018-03-16
Cochlear Americas
Nucleus 24 Cochlear Implant System2018-03-16
Cochlear Americas
Nucleus Auditory Brainstem Implant System2018-03-02
Cochlear Americas
Nucleus 24 Cochlear Implant System2018-03-02
Cochlear Americas
Nucleus Auditory Brainstem Implant System2018-02-14
Cochlear Americas
Nucleus 24 Cochlear Implant System2018-02-14
Cochlear Americas
Nucleus 24 Cochlear Implant System2018-02-01
Cochlear Americas
Necleus 24 Cochlear Implant System2018-02-01

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

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