Finland FDA 510(k) Overview
29
Manufacturers
67
Submissions
99%
Clearance rate
Leading Finland FDA 510(k) manufacturers include Vyaire Medical, Inc., Wipak OY, Planmed OY and 29 others.
Finnish medical device manufacturers have submitted 67 FDA 510(k) notifications since 2018, with a 98.5% clearance rate across 29 manufacturers. Finland's medtech sector shows concentration in patient monitoring, neurology devices and diagnostic imaging, reflecting the country's strength in technology-driven healthcare solutions.
Active in FDA 510(k) submissions since 2018. Many Finland manufacturers work with FDA regulatory consultants to support U.S. market entry.