Cochlear Ltd
LANE COVE New South Wales, AU
COCHLEAR LTD. appears in FDA device records in LANE COVE New South Wales, AU. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Cochlear Ltd between 2023 and 2025. The busiest year on record is 2023, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | LXB | Substantially Equivalent | |
| K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App | PFO | Substantially Equivalent | |
| K223672 | Instrument Case P1340904 | KCT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002806740 | 3002806740 | COCHLEAR LTD. | 14 MARS ROAD, LANE COVE New South Wales 2066 AU | 2026 | |
| 3009092818 | 3009092818 | Cochlear Ltd | 1 University Ave, Macquarie University New South Wales 2109 AU | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PFOActive Implantable Bone Conduction Hearing System
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- LXBHearing Aid, Bone Conduction
- MHEImplant, Auditory Brainstem
- MCMImplant, Cochlear
- LRCInstrument, Ent Manual Surgical
- OUGMedical Device Data System
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain