Edwards Lifesciences, LLC

Edwards Lifesciences, LLC — FDA 510(k) Submissions

Edwards Lifesciences, LLC has submitted 135 FDA 510(k) premarket notifications since 1979, of which 129 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Computer, Diagnostic, Programmable, Computer, Diagnostic, Pre-programmed, Single-function, System, Measurement, Blood-pressure, Non-invasive, Ring, Annuloplasty . Use the specialty filter in the sidebar to narrow results.