Panels › Ophthalmic › Product code KYF · Class 2
Implant, Eye Valve
Regulation 886.3920
0510(k)s in 12 months (25 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in KYF
| Company | 510(k)s | Recalls |
|---|---|---|
| New World Medical, Inc. | 9 | 0 |
| Eagle Vision Inc | 0 | 4 |
| Iop, Inc. | 3 | 0 |
| Allergan, Inc. | 1 | 1 |
| Hood Laboratories | 2 | 0 |
| Optonol, Ltd. | 2 | 0 |
| Glaukos Corporation | 1 | 0 |
| Innovative Ophthalmic Products, Inc | 0 | 1 |
| Innovative Ophthalmic Products, Inc. (Iop) | 1 | 0 |
| Optimed, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2019 | Allergan PLC XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment. Open, Classified |
KYF | K161457 |
| Feb 22, 2016 | Innovative Ophthalmic Products, Inc Molteno3 Glaucoma Implants G-Series:
GS-Single Plate 175mm2 (IOP reorder#: M3-175)
GL-Single Plate 230mm2 (IOP reorder#: M3-230) Terminated |
KYF | K062252 |
| May 6, 2006 | Eagle Vision Inc Valve-EV Glaucoma Ultra-Smooth, P/N 6006 Terminated |
KYF | K905703 |
| May 6, 2006 | Eagle Vision Inc Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V Terminated |
KYF | K905703 |
| May 6, 2006 | Eagle Vision Inc Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V Terminated |
KYF | K905703 |
| May 6, 2006 | Eagle Vision Inc Krupin Eye Valve, P/N 6003 Terminated |
KYF | K905703 |
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