Merit Medical Systems, Inc. - FDA 510(k) Cleared Devices

Merit Medical Systems, Inc. is a leading manufacturer of disposable medical devices for interventional, diagnostic, and therapeutic procedures. Based in South Jordan, the company serves hospitals and physicians worldwide.

Merit Medical has established a strong FDA 510(k) regulatory record since its first clearance in 1988. The company has received 169 FDA 510(k) clearances from 177 total submissions. Recent clearances span cardiovascular devices, neurology, gastroenterology, and general surgery, demonstrating broad clinical expertise. The latest clearance in 2026 confirms the company remains actively engaged in device innovation and regulatory compliance.

Merit Medical's recent cleared devices include ablation systems, surgical guidance platforms, vascular access products, stent systems, and angiographic catheters. The company's portfolio reflects particular strength in cardiovascular interventional devices, including introducers, delivery systems, and vascular plugs. This focus aligns with Merit Medical's historical specialization in cardiology, radiology, oncology, and critical care applications.

Explore the full database to review specific device names, product codes, and FDA 510(k) clearance dates for Merit Medical Systems, Inc.

Regulatory submissions have been managed by Merit Medical Systems, Inc., Merit Medical Ireland, Ltd. and Biosphere Medical, S.A..