Medical Device Manufacturer · US , Englewood , CO

Cochlear Americas - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2008
20
Total
20
Cleared
0
Denied

Cochlear Americas has 20 FDA 510(k) cleared ear, nose, throat devices. Based in Englewood, US.

Latest FDA clearance: Apr 2024. 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.

FDA 510(k) Regulatory Record - Cochlear Americas
20 devices
1-20 of 20
Cleared Apr 18, 2024
Cochlear Osia System
K240155 · PFO
Ear, Nose, Throat · 90d
Cleared Aug 24, 2023
Instrument Case
K231604 · KCT
General Hospital · 84d
Cleared Jul 27, 2022
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound...
K220922 · PFO
Ear, Nose, Throat · 118d
Cleared Sep 29, 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha...
K212136 · LXB
Ear, Nose, Throat · 83d
Cleared Feb 23, 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6,...
K202048 · LXB
Ear, Nose, Throat · 214d
Cleared Nov 15, 2019
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting...
K191921 · PFO
Ear, Nose, Throat · 120d
Cleared Jul 03, 2019
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia...
K190589 · PFO
Ear, Nose, Throat · 118d
Cleared Dec 19, 2018
BA310 Abutment, BIA310 Implant/Abutment
K182116 · MAH
Ear, Nose, Throat · 135d
Cleared Jun 07, 2017
Cochlear Baha SoundArc
K171088 · LXB
Ear, Nose, Throat · 56d
Cleared May 20, 2016
Baha 5 Power Sound Processor
K161123 · LXB
Ear, Nose, Throat · 29d
Cleared Mar 02, 2016
Baha 5 Super Power Sound Processor
K153245 · LXB
Ear, Nose, Throat · 114d
Cleared Jul 22, 2015
Cordelle II Sound Processor
K150751 · LXB
Ear, Nose, Throat · 121d
Cleared Jul 15, 2015
BA400 14mm Abutment
K150555 · MAH
Ear, Nose, Throat · 133d
Cleared Mar 25, 2015
Baha 5 Sound Processor
K142907 · LXB
Ear, Nose, Throat · 170d
Cleared Nov 07, 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · LXB
Ear, Nose, Throat · 190d
Cleared Sep 26, 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · LXB
Ear, Nose, Throat · 65d
Cleared Oct 12, 2012
COCHLEAR BAHA IMPLANT SYSTEM
K121317 · MAH
Ear, Nose, Throat · 163d
Cleared May 10, 2011
BAHA 3 POWER SOUND PROCESSOR
K110996 · LXB
Ear, Nose, Throat · 29d
Cleared Jul 13, 2010
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360 · LXB
Ear, Nose, Throat · 151d
Cleared Aug 28, 2008
BAHA INTENSO
K081606 · LXB
Ear, Nose, Throat · 83d
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