FDA Registration
Active
🇺🇸 United States
Cochlear Americas Warehouse
Reg #: 3014579188
·
FEI: 3014579188
·
Expires 2026
Products
13
Proprietary Names
52
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- Cochlear Americas Warehouse
- Registration Number
- 3014579188
- FEI Number
- 3014579188
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7101 S. Fulton St., Suite E
- City
- Centennial
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223672
- PMA Number
- P840024
Owner / Operator
- Firm Name
- COCHLEAR AMERICAS
- Operator Number
- 9076254
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- Postal Code
- 80124
- Country
- US
- Correspondent
- Laura - Blair
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-09-13 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2016-05-31 |
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2019-11-19 |
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2005-08-10 |
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2012-11-19 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2006-09-19 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2018-10-29 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2013-10-24 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2003-03-18 |
| Implant, Auditory Brainstem | MHE | Class 3 | Unknown | No | 2005-08-10 |
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | Class 3 | Unknown | No | 2014-04-16 |
| 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 |
Proprietary Names
Instrument Case
Baha 5 Power
Osia 2 System
Baha BIA300 Implants with Abutments
N22 COCHLEAR IMPLANT SYS FOR ADULTS
Baha Cordelle II Sound Processor
Baha BA400 Abutment
Disposable Biopsy Punch
Medical Device Disinfectant
Cochlear OsiaTM System
SoundArc
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
Cochlear Baha 7 System
Baha Smart App
Baha 7 Sound Processor and Accessories
Cochlear SoundBand
Baha Fitting Software 7
Headband for Baha
Baha 6 Max Sound Processor
Baha Fitting Software 6
7M Magnet for CP1000 5(I) Coils
Instrument Case (Phase 2)
Baha Vistafix
Baha 5
Baha Attract
Nucleus Auditory Brainstem Implant System
N22 COCHLEAR IMPLANT SYS FOR PED
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
Nucleus Hybrid L24 Implant System
BAHA IMPLANT SYSTEM
Ba400 14mm Abutment
Cochlear Osia® System
ENT Surgical
BA310 Abutment, BIA310 Implant/Abutment
Baha 5 SuperPower Sound Processor
Osscora Surgical Set
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device