Medical Device Manufacturer · US , Rockville , MD

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

16 submissions · 16 cleared · Since 2005

Total

Cleared

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.

Kowa Co. , Ltd. is one of 5639 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Kowa Co. , Ltd.

16 devices

1-16 of 16

KOWA, FM-600, MODEL LSS50

MODIFICATION TO KOWA NONMYD ALPHA-DIII

K083387 · HKI

Ophthalmic · 60d

Cleared Oct 21, 2008

KOWA NONMYD ALPHA-DIII

KOWA NONMYD 7, KOWA NONMYD A-D

K053026 · HKI

Ophthalmic · 14d

Cleared Nov 03, 2005

KOWA GENESIS-D HAND-HELD RETINAL CAMERA

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

FDA 510(k) Regulatory Record - Kowa Co. , Ltd.

Filters