Known Identifiers & Locations
FEI Numbers
3002806315
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 (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0026-2026 |
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
|
2025-08-18 |
Open, Classified
|
View Details
|
| Z-0027-2026 |
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
|
2025-08-18 |
Open, Classified
|
View Details
|
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