Known Identifiers & Locations
FEI Numbers
1000220815
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-0044-05 |
Advanced Bionics implantable cochlear stimulator CLARION 1.2
Models
AB-5100L
AB-5100R
AB-5100ML/R (For Export Only)
AB-5100H
AB-5100H-01A
Reason: All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
|
2004-09-27 |
Terminated
|
View Details
|
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