Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices

Samsung Electronics Co., Ltd. is a South Korean multinational electronics corporation headquartered in Suwon. The company maintains a regulatory presence in the United States through its Echo, US location.

Samsung has submitted 40 total applications for FDA 510(k) clearance and received 39 clearances. The company's regulatory focus centers on Radiology devices, which represent 83% of submissions. Samsung's FDA 510(k) clearance history spans from 2013 to 2024, with recent clearances demonstrating continued regulatory activity in medical imaging and cardiovascular monitoring technologies.

As a global technology leader, Samsung operates assembly plants and sales networks across 76 countries and employs over 260,000 people. The company is recognized for innovation in semiconductors, displays, and consumer electronics. Within medical devices, Samsung has expanded into diagnostic imaging, cardiac monitoring applications, and hospital support systems.

Explore the complete record of Samsung's FDA 510(k) cleared devices, including product codes, submission dates, and clearance timelines in the database.