Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices

Edwards Lifesciences, LLC is a global structural heart innovation company headquartered in Irvine, California. The company specializes in advanced medical devices for cardiovascular disease management.

Edwards Lifesciences has established a strong FDA 510(k) regulatory track record with 129 FDA 510(k) cleared devices from 135 total submissions since 1979. The company's portfolio is dominated by Cardiovascular devices, which represent 88% of all submissions. The latest clearance was received in 2026, demonstrating continued active development and regulatory engagement.

Recent cleared devices include transcatheter heart valve technologies, annuloplasty rings, hemodynamic monitoring systems, and specialized catheters for structural heart interventions. The company's product portfolio reflects deep expertise in both transcatheter and surgical heart valve solutions, as well as critical care monitoring technologies.

Explore the complete list of device names, product codes, and individual clearance dates in the database to review Edwards Lifesciences' full regulatory history.

510(k) submissions have been managed by Edwards Lifesciences, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.