Medical Device Manufacturer · US , Rockville , MD

Kowa Co. , Ltd. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2005

16

Total

16

Cleared

0

Denied

Kowa Co. , Ltd. — FDA 510(k) Products and Clearance History Ophthalmic ✕

16 devices

1-16 of 16

Cleared Mar 11, 2014

Ophthalmic · 92d

Cleared Feb 16, 2012

Ophthalmic · 188d

Cleared Jan 26, 2011

Ophthalmic · 230d

Cleared Aug 07, 2009

KOWA, FM-600, MODEL LSS50

Ophthalmic · 116d

Cleared Aug 07, 2009

Ophthalmic · 113d

Cleared Jul 02, 2009

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

Ophthalmic · 25d

Cleared Dec 18, 2006

Ophthalmic · 11d

Cleared Nov 01, 2006

Ophthalmic · 107d

Cleared Sep 27, 2006

KOWA NONMYD ALPHA-D

Ophthalmic · 44d

Cleared Jun 09, 2006

Ophthalmic · 182d

Cleared Nov 10, 2005

KOWA NONMYD 7, KOWA NONMYD A-D

Ophthalmic · 14d

Cleared Nov 03, 2005

KOWA GENESIS-D HAND-HELD RETINAL CAMERA

Ophthalmic · 272d

Cleared Oct 06, 2005

Ophthalmic · 321d