FDA Registration
Active
🇺🇸 United States
COCHLEAR AMERICAS
Reg #: 3005900820
·
FEI: 3005900820
·
Expires 2026
Products
14
Proprietary Names
56
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- COCHLEAR AMERICAS
- Registration Number
- 3005900820
- FEI Number
- 3005900820
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- ZIP
- 80124
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002913
- PMA Number
- P000015
Owner / Operator
- Firm Name
- COCHLEAR AMERICAS
- Operator Number
- 9076254
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- Postal Code
- 80124
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2008-10-23 |
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2019-11-19 |
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2012-11-19 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-09-13 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2013-10-24 |
| Implant, Auditory Brainstem | MHE | Class 3 | Unknown | No | 2005-08-10 |
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2005-08-10 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2012-05-29 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2003-03-07 |
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | Class 3 | Unknown | No | 2014-04-16 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2018-10-29 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2006-09-19 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2014-01-06 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2003-03-18 |
Proprietary Names
Headband for Baha
Osia 2 System
Cochlear OsiaTM System
Baha BA400 Abutment
Cochlear Baha 7 System
Baha Smart App
Baha 7 Sound Processor and Accessories
Cochlear SoundBand
Baha Fitting Software 7
Baha Cordelle II Sound Processor
Instrument Case (Phase 2)
Baha 5
Cochlear Baha Remote Control
Cochlear Wireless Mini Microphone
Cochlear Wireless TV Streamer
Cochlear Wireless Phone Clip
Cochlear Baha Control App
Mini Microphone Pro
Mini Microphone 2
Nucleus Auditory Brainstem Implant System
Baha 5 Power
ENT Surgical
Osscora Surgical Set
Nucleus Hybrid L24 Implant System
Medical Device Disinfectant
BAHA IMPLANT SYSTEM
Ba400 14mm Abutment
SoundArc
BA310 Abutment, BIA310 Implant/Abutment
Disposable Biopsy Punch
N22 COCHLEAR IMPLANT SYS FOR PED
7M Magnet for CP1000 5(I) Coils
Cochlear Baha® Fitting Software 6
Cochlear Baha® Baha Smart App
Cochlear Baha® System
Baha BIA300 Implants with Abutments
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Cochlear Surgical Instrument Upgrade Kit
Nucleus SmartNav
Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories
Cochlear Nucleus 8 Nexa Sound Processor and Accessories
Cochlear Nucleus Nexa cochlear implants
Cochlear Nucleus Kanso 3 Sound Processor and accessories
Nucleus Smart App
Cochlear Objective Measures
Cochlear surgical processors and accessories
Custom Sound Pro
Instrument Case
Baha 6 Max Sound Processor
Baha Fitting Software 6
Baha 5 SuperPower Sound Processor
N22 COCHLEAR IMPLANT SYS FOR ADULTS
Cochlear Osia® System
Medical Device Data System
Baha Vistafix
Baha Attract
Establishment Types
Complaint File Establishment per 21 CFR 820.198