Atlas FDA

Cochlear Americas

21 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System (K260902)Cochlear Americas2026-07-10
Cochlear Osia System (K240155)Cochlear Americas2024-04-18
Instrument Case (K231604)Cochlear Americas2023-08-24
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (K220922)Cochlear Americas2022-07-27
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136)Cochlear Americas2021-09-29
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (K202048)Cochlear Americas2021-02-23
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (K191921)Cochlear Americas2019-11-15
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (K190589)Cochlear Americas2019-07-03
BA310 Abutment, BIA310 Implant/Abutment (K182116)Cochlear Americas2018-12-19
Cochlear Baha SoundArc (K171088)Cochlear Americas2017-06-07
Baha 5 Power Sound Processor (K161123)Cochlear Americas2016-05-20
Baha 5 Super Power Sound Processor (K153245)Cochlear Americas2016-03-02
Cordelle II Sound Processor (K150751)Cochlear Americas2015-07-22
BA400 14mm Abutment (K150555)Cochlear Americas2015-07-15
Baha 5 Sound Processor (K142907)Cochlear Americas2015-03-25
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT (K131240)Cochlear Americas2013-11-07
COCHLEAR BAHA 4 SOUND PROCESSOR (K132278)Cochlear Americas2013-09-26
COCHLEAR BAHA IMPLANT SYSTEM (K121317)Cochlear Americas2012-10-12
BAHA 3 POWER SOUND PROCESSOR (K110996)Cochlear Americas2011-05-10
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT (K100360)Cochlear Americas2010-07-13
BAHA INTENSO (K081606)Cochlear Americas2008-08-28

Track Cochlear Americas automatically

Every clearance here is in the API, with alerts when new ones post.