FDA 510(k) Applications Submitted by Cochlear Americas
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K171088 |
04/12/2017 |
Cochlear Baha SoundArc |
Cochlear Americas |
| K182116 |
08/06/2018 |
BA310 Abutment, BIA310 Implant/Abutment |
Cochlear Americas |
| K191921 |
07/18/2019 |
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments |
Cochlear Americas |
| K202048 |
07/24/2020 |
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App |
Cochlear Americas |
| K190589 |
03/07/2019 |
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments |
Cochlear Americas |
| K150751 |
03/23/2015 |
Cordelle II Sound Processor |
COCHLEAR AMERICAS |
| K161123 |
04/21/2016 |
Baha 5 Power Sound Processor |
Cochlear Americas |
| K220922 |
03/31/2022 |
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit |
Cochlear Americas |
| K100360 |
02/12/2010 |
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT |
COCHLEAR AMERICAS |
| K110996 |
04/11/2011 |
BAHA 3 POWER SOUND PROCESSOR |
COCHLEAR AMERICAS |
| K131240 |
05/01/2013 |
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT |
COCHLEAR AMERICAS |
| K121317 |
05/02/2012 |
COCHLEAR BAHA IMPLANT SYSTEM |
COCHLEAR AMERICAS |
| K081606 |
06/06/2008 |
BAHA INTENSO |
COCHLEAR AMERICAS |
| K132278 |
07/23/2013 |
COCHLEAR BAHA 4 SOUND PROCESSOR |
COCHLEAR AMERICAS |
| K142907 |
10/06/2014 |
Baha 5 Sound Processor |
COCHLEAR AMERICAS |
| K150555 |
03/04/2015 |
BA400 14mm Abutment |
COCHLEAR AMERICAS |
| K153245 |
11/09/2015 |
Baha 5 Super Power Sound Processor |
COCHLEAR AMERICAS |
| K231604 |
06/01/2023 |
Instrument Case |
Cochlear Americas |
| K212136 |
07/08/2021 |
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App |
Cochlear Americas |
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