510(k) Report

FDA applicant

Icn Pharmaceuticals, Inc.

Orangeburg, NY30 decisions1977–20020 recalls

FDA records 30 decisions for Icn Pharmaceuticals, Inc. (Orangeburg, NY) from 1977 to 2002: 30 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, clinical chemistry panel, where it files most

How often FDA has decided Icn Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icn Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Icn Pharmaceuticals, 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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