FDA applicant

Edwards Lfesciences

Irvine, CA1 decision2021–20210 recalls

FDA records 1 decision for Edwards Lfesciences (Irvine, CA) in 2021: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Edwards Lfesciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Edwards Lfesciences by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Edwards Lfesciences’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Edwards”

FDA records each applicant name separately; these may or may not be the same firm.

Edwards Lifesciences, LLC 177 Edwards Pacemaker Systems 13 Edwards Laboratories 12 Edwards Lifesciences Research Medical 6 Edwards Lifesciences Services GmbH 3 Edwards Lifeciences, LLC 3 Edwards Lifesiences, LLC 2 Edwards Orthopaedics Div., Baxter Healthcare Corp. 2 Edwards Lifesciencess, LLC 1 Edwards Lifescience, LLC 1 Edwards Ventilator Co. 1

Edwards Lfesciences

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Edwards”