COCHLEAR AMERICAS

Entity profile compiled from public source records

Public Record Profile Registrations: 7 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 3002806740, 3003045432, 3003222064, 3005900820, 3009092818, 3013177549, 3014579188
Owner Operator Numbers 9076254
Locations Covered Centennial, CO, US; Kuala Lumpur Kuala Lumpur, MY; LANE COVE New South Wales, AU; Lone Tree, CO, US; Macquarie University New South Wales, AU; Molnlycke Vastra Gotaland, SE; Newstead Queensland, AU

Registered Establishments (7)

Registration # Establishment Name Location Establishment Type(s) Action
3002806740 COCHLEAR LTD. LANE COVE New South Wales, AU Manufacture Medical Device View Details
3005900820 COCHLEAR AMERICAS Lone Tree, CO, US Complaint File Establishment per 21 CFR 820.198 View Details
3009092818 Cochlear Ltd Macquarie University New South Wales, AU Repack or Relabel Medical Device,Manufacture Medical Device View Details
3013177549 Cochlear Malaysia Sdn Bhd Kuala Lumpur Kuala Lumpur, MY Complaint File Establishment per 21 CFR 820.198 View Details
3014579188 Cochlear Americas Warehouse Centennial, CO, US Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198 View Details
9613646 Cochlear Limited - Brisbane Newstead Queensland, AU Manufacture Medical Device View Details
9616024 COCHLEAR BONE ANCHORED SOLUTIONS AB Molnlycke Vastra Gotaland, SE Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.