Cochlear Americas - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) cleared devices by Cochlear Americas Ear, Nose, Throat ✕
19 devices
Cleared
Apr 18, 2024
Cochlear Osia System
Ear, Nose, Throat
90d
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
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
Cleared
Jul 22, 2015
Cordelle II Sound Processor
Ear, Nose, Throat
121d
Cleared
Jul 15, 2015
BA400 14mm Abutment
Ear, Nose, Throat
133d
Cleared
Mar 25, 2015
Baha 5 Sound Processor
Ear, Nose, Throat
170d
Cleared
Nov 07, 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
Ear, Nose, Throat
190d
Cleared
Sep 26, 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
Ear, Nose, Throat
65d
Cleared
Oct 12, 2012
COCHLEAR BAHA IMPLANT SYSTEM
Ear, Nose, Throat
163d
Cleared
May 10, 2011
BAHA 3 POWER SOUND PROCESSOR
Ear, Nose, Throat
29d
Cleared
Jul 13, 2010
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
Ear, Nose, Throat
151d
Cleared
Aug 28, 2008
BAHA INTENSO
Ear, Nose, Throat
83d