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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2023 | K231051 | Ahmed® Glaucoma Valve Model FP8 New World Medical, Inc. | KYF |
| May 12, 2023 | K230975 | Ahmed® Glaucoma Valve Model FP7 New World Medical, Inc. | KYF |
| Aug 2, 2022 | K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 Glaukos Corporation | KYF |
| Jan 18, 2019 | K182518 | AHMED ClearPath Glaucoma Drainage Device New World Medical, Inc. | KYF |
| Aug 8, 2017 | K171451 | Ahmed Glaucoma Valve Model FP8 New World Medical, Inc. | KYF |
| Nov 21, 2016 | K161457 | XEN Glaucoma Treatment System Allergan, Inc. | KYF |
| Oct 24, 2016 | K162060 | Ahmed Glaucoma Valve New World Medical, Inc. | KYF |
| Dec 17, 2015 | K152996 | Molteno3 Glaucoma Implant Innovative Ophthalmic Products, Inc. (Iop) | KYF |
| Sep 27, 2006 | K062252 | MOLTENO3 Iop, Inc. | KYF |
| Sep 18, 2006 | K060644 | AHMED GLAUCOMA VALVE, MODEL M4 New World Medical, Inc. | KYF |
| Mar 13, 2003 | K030350 | EXPRESS MINI GLAUCOMA SHUNT Optonol, Ltd. | KYF |
| Mar 26, 2002 | K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS Optonol, Ltd. | KYF |
| Jul 13, 1999 | K991072 | AHMED GLAUCOMA VALVE IMPLANT New World Medical, Inc. | KYF |
| Apr 20, 1998 | K980657 | AHMED GLAUCOMA VALVE, MODEL S3 New World Medical, Inc. | KYF |
| Feb 18, 1997 | K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT Pharmacia Iovision, Inc. | KYF |
| Nov 12, 1993 | K925636 | AHMED GLAUCOMA VALVE IMPLANT New World Medical, Inc. | KYF |
| Mar 15, 1991 | K905703 | KRUPIN EYE VALVE WITH DISK Hood Laboratories | KYF |
| Mar 14, 1991 | K902296 | TRABECULO-SUPRACHOROIDAL SHUNT Visionex, Inc. | KYF |
| Feb 11, 1991 | K905129 | BAERVELDT GLAUCOMA IMPLANT Wright Medical Corp. | KYF |
| Oct 16, 1990 | K903462 | OPTIMED GLAUCOMA PRESSURE REGULATOR Optimed, Inc. | KYF |
| Aug 14, 1990 | K902489 | MODIFIED MOLTENO(TM) IMPLANTS Iop, Inc. | KYF |
| Feb 27, 1989 | K890598 | MOLTENO IMPLANT Iop, Inc. | KYF |
| Jan 24, 1989 | K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE Hood Laboratories | KYF |
| Mar 30, 1988 | K875099 | MOLTENO VALVE SETON Staar Surgical Co. | KYF |
| Feb 15, 1985 | K840204 | WHITE OCULAR PRESSURE RELIEF DEVICE Precision-Cosmet Co., Inc. | KYF |
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