FDA applicant
Edwards Lifesciences, LLC
FDA records 177 decisions for Edwards Lifesciences, LLC (Irvine, CA) from 1979 to 2026: 156 510(k) clearances, 2 De Novo grants and 19 original PMA approvals. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 247 predicates, 116 of them its own earlier devices. 180 recalls are linked to its devices, 12 Class I.
FDA’s records also spell it “Edwards Lifesciences”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Edwards Lifesciences, LLC’s devices, and how often a recall has named them.
FDA decisions per year
10in 2025
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like Edwards Lifesciences, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Edwards”
FDA records each applicant name separately; these may or may not be the same firm.