FDA applicant

Edwards Lifesciencess, LLC

Irvine, CA1 decision2023–20232 recalls

FDA records 1 decision for Edwards Lifesciencess, LLC (Irvine, CA) in 2023: 1 510(k) clearance. All are in product code DYG (Catheter, Flow Directed). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 recalls are 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 Lifesciencess, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

2in 2026

2023high 2 (2026) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Edwards Lifesciencess, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Lfesciences 1 Edwards Lifescience, LLC 1 Edwards Ventilator Co. 1

Edwards Lifesciencess, LLC

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?

What has been recalled?

Other applicant names beginning “Edwards”