FDA applicant

Edwards Lifeciences, LLC

Irvine, CA3 decisions2019–20222 recalls

FDA records 3 decisions for Edwards Lifeciences, LLC (Irvine, CA) from 2019 to 2022: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and QAQ (Adjunctive Predictive Cardiovascular Indicator). Its devices cite 5 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 Lifeciences, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

2in 2023

2019high 2 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Edwards Lifeciences, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Edwards Lifeciences, LLC’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 Lifesiences, LLC 2 Edwards Orthopaedics Div., Baxter Healthcare Corp. 2 Edwards Lifesciencess, LLC 1 Edwards Lfesciences 1 Edwards Lifescience, LLC 1 Edwards Ventilator Co. 1

Edwards Lifeciences, 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?

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Other applicant names beginning “Edwards”