FDA 510(k) Medical Device Manufacturers - South Korea

Leading South Korea FDA 510(k) manufacturers include Samsung Medison Co., Ltd., Osstem Implant Co., Ltd., L & K Biomed Co., Ltd. and 437 others.

South Korean medical device manufacturers have submitted 1,545 FDA 510(k) notifications since 1996, with a 99.9% clearance rate across 440 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 1996. Many South Korea manufacturers work with FDA regulatory consultants to support U.S. market entry.