Known Identifiers & Locations
FEI Numbers
2522801
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-0026-04 |
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Reason: text on product handle is incorrect
|
2003-08-21 |
Terminated
|
View Details
|
| Z-0034-2009 |
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Reason: mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
|
2008-09-09 |
Terminated
|
View Details
|
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