Known Identifiers & Locations
FEI Numbers
3005900820
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0003-2012 |
Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia.
The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Reason: Cochlear implant may shut down and cease to function.
|
2011-09-16 |
Terminated
|
View Details
|
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.