South Korea FDA 510(k) Overview
Leading South Korea FDA 510(k) manufacturers include Samsung Medison Co., Ltd., L & K Biomed Co., Ltd., Wontech Co., Ltd. and 348 others.
South Korean medical device manufacturers have submitted 1,034 FDA 510(k) notifications since 2018, with a 99.9% clearance rate across 350 manufacturers. South Korea's medtech industry shows strong activity in dental devices, diagnostic imaging and in vitro diagnostics, reflecting the country's growing global medical device export capacity.
Active in FDA 510(k) submissions since 2018. Many South Korea manufacturers work with FDA regulatory consultants to support U.S. market entry.