510(k) Report

FDA applicant

Action Medical Systems, Inc.

Mchenry, IL2 decisions1981–19830 recalls

FDA records 2 decisions for Action Medical Systems, Inc. (Mchenry, IL) from 1981 to 1983: 2 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and NAD (Dressing, Wound, Occlusive). 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, general and plastic surgery panel, where it files most

How often FDA has decided Action Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Action Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Action Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Action Medical Systems, Inc.’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 “Action”

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