Optomed OY - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Optomed OY has 5 FDA 510(k) cleared medical devices. Based in Oulu, FI.
Historical record: 5 cleared submissions from 2009 to 2018. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Optomed OY Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Optomed OY
5 devices
Cleared
Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Ophthalmic
52d
Cleared
Apr 11, 2017
HAAG-STREIT FUNDUS MODULE 300
Ophthalmic
162d
Cleared
Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
Ophthalmic
156d
Cleared
May 16, 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
Ophthalmic
38d
Cleared
Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
Ophthalmic
86d