Edwards Lifesciences - FDA 510(k) Cleared Devices

Edwards Lifesciences, is the leading global structural heart innovation company dedicated to improving patient lives through breakthrough cardiovascular technologies. The company partners with physicians to develop products for patients fighting heart disease, with a manufacturing facility in Irvine, US.

Edwards Lifesciences has received 19 FDA 510(k) clearances from 20 total submissions since 2011. The company specializes in Cardiovascular devices, which represent the dominant focus of its regulatory portfolio. The latest clearance in 2025 reflects continued innovation and active market engagement.

The company's cleared devices include transcatheter heart valve systems, advanced monitoring platforms, arterial embolectomy catheters, and introducer sets. These products support both structural heart interventions and critical care monitoring across multiple clinical specialties.

Explore the complete list of device names, product codes, and clearance dates in the database to learn more about Edwards Lifesciences' regulatory history and cleared innovations.