Edwards Lifesciences

Edwards Lifesciences — FDA 510(k) Submissions

Edwards Lifesciences has submitted 19 FDA 510(k) premarket notifications since 2011, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Introducer, Catheter, Computer, Diagnostic, Programmable, Catheter, Embolectomy, Catheter, Flow Directed, Adjunctive Open Loop Fluid Therapy Recommender . Use the specialty filter in the sidebar to narrow results.