Topcon Healthcare Solutions EMEA Oy is one of 32 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Topcon Healthcare Solutions EMEA Oy - FDA 510(k) Cleared Devices
Recent clearances: Harmony Referral System with Harmony OCT Viewer (Octave), Harmony Referral System
2
Total
2
Cleared
0
Denied
Topcon Healthcare Solutions EMEA Oy has 2 FDA 510(k) cleared medical devices. Based in Oulu, FI.
Latest FDA clearance: Jun 2026. Active since 2021. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Topcon Healthcare Solutions EMEA Oy Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by O'Connell Regulatory Consultants, Inc. and Topcon Healthcare, Inc..
FDA 510(k) Regulatory Record - Topcon Healthcare Solutions EMEA Oy
2 devices