FDA applicant

Edwards Ventilator Co.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Edwards Ventilator Co. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code BYT (Ventilator, External Body, Negative Pressure…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Edwards Ventilator Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Edwards Ventilator Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Edwards”