FDA applicant

Arden Laboratories, Incorporated

Willernie, MN1 decision2003–20030 recalls

FDA records 1 decision for Arden Laboratories, Incorporated (Willernie, MN) in 2003: 1 510(k) clearance. All are in product code FRC (Indicator, Biological Sterilization Process). 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 hospital panel, where it files most

How often FDA has decided Arden Laboratories, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arden Laboratories, Incorporated since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arden Laboratories, Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Arden”

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

Arden Medical Systems, Inc. 3 Arden Sales, Inc. 1

Arden Laboratories, Incorporated

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Arden”