FDA applicant

Edwards Laboratories

Mchenry, IL12 decisions1976–19800 recalls

FDA records 12 decisions for Edwards Laboratories (Mchenry, IL) from 1976 to 1980: 12 510(k) clearances. Most are in product codes DXG (Computer, Diagnostic, Pre-Programmed…) and DTK (Filter, Intravascular, Cardiovascular). 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 Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Edwards Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Edwards Laboratories by year, 2007–2026Sources: 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 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 Lfesciences 1 Edwards Lifescience, LLC 1 Edwards Ventilator Co. 1

Edwards Laboratories

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Edwards”