Merit Medical Systems - FDA 510(k) Cleared Devices

Merit Medical Systems, is a leading manufacturer of disposable medical devices used in interventional, diagnostic, and therapeutic procedures. Founded in 1987, the company serves hospitals and physicians worldwide with a manufacturing facility in South Jordan, Utah. Merit employs approximately 7,000 people globally and operates across multiple therapeutic areas including cardiology, radiology, oncology, critical care, and endoscopy.

The company has received 1 FDA 510(k) clearance from 1 total submission. Merit's regulatory focus centers on Cardiovascular devices, with its cleared device being the Prelude IDeal 9F Hydrophilic Sheath Introducer. The company's first and latest FDA 510(k) clearance occurred in 2022. Merit is currently inactive in the FDA 510(k) database, with no new clearances in more than five years, and should be treated as a historical regulatory record.

Merit's product portfolio spans diverse procedural categories including biopsy solutions, cardiac catheterization, critical care devices, dialysis access, drainage solutions, and embolotherapy systems. The company maintains a global presence across Asia, Europe, the Middle East, Africa, North America, Oceania, and South America, supporting healthcare systems with clinically proven interventional solutions.

Explore the company's cleared device names, product codes, and complete 510(k) clearance dates in the database records above.