Kowa Co. , Ltd. is one of 5639 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Kowa Co. , Ltd. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Kowa Co. , Ltd. has 16 FDA 510(k) cleared ophthalmic devices. Based in Rockville, US.
Historical record: 16 cleared submissions from 2005 to 2014.
Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Kowa Co. , Ltd.
16 devices
Cleared
Mar 11, 2014
KOWA SL-17
Ophthalmic
92d
Cleared
Feb 16, 2012
KOWA VX-20
Ophthalmic
188d
Cleared
Jan 26, 2011
KOWA NONMYD WX
Ophthalmic
230d
Cleared
Aug 07, 2009
KOWA, FM-600, MODEL LSS50
Ophthalmic
116d
Cleared
Aug 07, 2009
KOWAGENESIS-DF
Ophthalmic
113d
Cleared
Jul 02, 2009
KOWA VX-10 A
Ophthalmic
22d
Cleared
Jan 16, 2009
MODIFICATION TO KOWA NONMYD ALPHA-DIII
Ophthalmic
60d
Cleared
Oct 21, 2008
KOWA NONMYD ALPHA-DIII
Ophthalmic
29d
Cleared
Apr 04, 2008
KOWA GENESIS-D
Ophthalmic
25d
Cleared
Dec 18, 2006
KOWA SL-15
Ophthalmic
11d
Cleared
Nov 01, 2006
KOWA VX-10I
Ophthalmic
107d
Cleared
Sep 27, 2006
KOWA NONMYD ALPHA-D
Ophthalmic
44d