FDA 510(k) Applications for Medical Device Product Code "KYF"
(Implant, Eye Valve)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K161457 |
Allergan, Inc. |
XEN Glaucoma Treatment System |
11/21/2016 |
K220032 |
Glaukos Corporation |
iStent infinite Trabecular Micro-Bypass System, Model iS3 |
08/02/2022 |
K152996 |
INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) |
Molteno3 Glaucoma Implant |
12/17/2015 |
K062252 |
IOP, INC. |
MOLTENO3 |
09/27/2006 |
K182518 |
New World Medical, Inc. |
AHMED ClearPath Glaucoma Drainage Device |
01/18/2019 |
K162060 |
NEW WORLD MEDICAL, INC. |
Ahmed Glaucoma Valve |
10/24/2016 |
K991072 |
NEW WORLD MEDICAL, INC. |
AHMED GLAUCOMA VALVE IMPLANT |
07/13/1999 |
K171451 |
New World Medical, Inc. |
Ahmed Glaucoma Valve Model FP8 |
08/08/2017 |
K060644 |
NEW WORLD MEDICAL, INC. |
AHMED GLAUCOMA VALVE, MODEL M4 |
09/18/2006 |
K980657 |
NEW WORLD MEDICAL, INC. |
AHMED GLAUCOMA VALVE, MODEL S3 |
04/20/1998 |
K230975 |
New World Medical, Inc. |
Ahmed« Glaucoma Valve Model FP7 |
05/12/2023 |
K231051 |
New World Medical, Inc. |
Ahmed« Glaucoma Valve Model FP8 |
05/12/2023 |
K012852 |
OPTONOL, LTD |
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS |
03/26/2002 |
K030350 |
OPTONOL, LTD |
EXPRESS MINI GLAUCOMA SHUNT |
03/13/2003 |
K955455 |
PHARMACIA IOVISION, INC. |
BAERVELT PARS PLANA GLAUCOMA IMPLANT |
02/18/1997 |
|
|