Data / Medical devices / Australia / Cochlear Ltd.
Cochlear Ltd.: FDA-registered device maker in LANE COVE New South Wales, Australia, 5 PMA approvals
Cochlear Ltd. is registered with the FDA (registration 3002806740) in LANE COVE New South Wales, Australia. It lists 6 device types. The FDA files 5 PMA approvals under its listings, the newest dated March 20, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806740
- Address
- 14 Mars Road, LANE COVE New South Wales, Australia, 2066
- Owner or operator
- COCHLEAR AMERICAS (9076254)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 10, 2005
- Registered through
- 2027
- Brand names listed
- 7M Magnet for CP1000 5(I) Coils, Cochlear Nucleus 8 Nexa Sound Processor and Accessories, Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories, Cochlear Nucleus Kanso 3 Sound Processor and accessories, Cochlear Nucleus Nexa cochlear implants, Cochlear Objective Measures, Cochlear Surgical Instrument Upgrade Kit, Cochlear surgical processors and accessories and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Implant, Auditory Brainstem | MHE | 3 | Manufacturer | accessdata.fda.gov |
| Implant, Cochlear | MCM | 3 | Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | SEM | 2 | Contract manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 20, 2014 | P130016 | NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM | PGQ | 60 | September 28, 2026 | accessdata.fda.gov |
| October 20, 2000 | P000015 | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | MHE | 53 | September 28, 2026 | accessdata.fda.gov |
| June 25, 1998 | P970051 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | 225 | September 28, 2026 | accessdata.fda.gov |
| June 27, 1990 | P890027 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN | MCM | 65 | September 28, 2026 | accessdata.fda.gov |
| October 31, 1985 | P840024 | NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI | MCM | 95 | September 28, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
- All makers of Implant, Cochlear
- All makers of Instrument, Ent Manual Surgical
- All makers of Implant, Auditory Brainstem
- All makers of Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- All makers of Medical Device Data System
Updated September 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.