Cochlear Americas is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cochlear Americas - FDA 510(k) Cleared Devices
Recent clearances: Cochlear Osia System, Instrument Case, Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
21
Total
21
Cleared
0
Denied
Cochlear Americas has 21 FDA 510(k) cleared ear, nose, throat devices. Based in Englewood, US.
Latest FDA clearance: Jul 2026. Active since 2008.
Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Cochlear Americas
21 devices
Cleared
Jul 10, 2026
Cochlear™ Osia® 3(I) Sound Processor
Ear, Nose, Throat
114d
Cleared
Apr 18, 2024
Cochlear Osia System
Ear, Nose, Throat
90d
Cleared
Aug 24, 2023
Instrument Case
General Hospital
84d
Cleared
Jul 27, 2022
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound...
Ear, Nose, Throat
118d
Cleared
Sep 29, 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha...
Ear, Nose, Throat
83d
Cleared
Feb 23, 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6,...
Ear, Nose, Throat
214d
Cleared
Nov 15, 2019
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting...
Ear, Nose, Throat
120d
Cleared
CT
Jul 03, 2019
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia...
Ear, Nose, Throat
118d
Cleared
Dec 19, 2018
BA310 Abutment, BIA310 Implant/Abutment
Ear, Nose, Throat
135d
Cleared
Jun 07, 2017
Cochlear Baha SoundArc
Ear, Nose, Throat
56d
Cleared
May 20, 2016
Baha 5 Power Sound Processor
Ear, Nose, Throat
29d
Cleared
Mar 02, 2016
Baha 5 Super Power Sound Processor
Ear, Nose, Throat
114d