Biosense Webster, Inc. - FDA 510(k) Cleared Devices

Biosense Webster, Inc. has 73 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.

Latest FDA clearance: Feb 2026. Active since 1999.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Biosense Webster, Ltd. as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.