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.

20 devices
1–12 of 20
Cochlear Osia System
K240155 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat
Apr 2024 90d
Instrument Case
K231604 · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories · General Hospital
Aug 2023 84d
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
K220922 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat
Jul 2022 118d
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
K212136 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Sep 2021 83d
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
K202048 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Feb 2021 214d
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
K191921 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat
Nov 2019 120d
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
K190589 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat
Jul 2019 118d
BA310 Abutment, BIA310 Implant/Abutment
K182116 · MAH Hearing Aid, Bone Conduction, Implanted · Ear, Nose, Throat
Dec 2018 135d
Cochlear Baha SoundArc
K171088 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Jun 2017 56d
Baha 5 Power Sound Processor
K161123 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
May 2016 29d
Baha 5 Super Power Sound Processor
K153245 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Mar 2016 114d
Cordelle II Sound Processor
K150751 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat
Jul 2015 121d
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