Medical Device Manufacturer · US , Irvine , CA

Edwards Lifesiences, LLC

2 submissions · 2 cleared · Since 2020
2
Total
2
Cleared
0
Denied

Edwards Lifesiences, LLC — FDA 510(k) Submissions

Edwards Lifesiences, LLC has submitted 2 FDA 510(k) premarket notifications since 2020, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Programmable, Catheter, Flow Directed . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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All2 Cardiovascular 2