FDA applicant

Loredan Biomedical, Inc.

Davis, CA9 decisions1983–19930 recalls

FDA records 9 decisions for Loredan Biomedical, Inc. (Davis, CA) from 1983 to 1993: 9 510(k) clearances. Most are in product codes IKK (System, Isokinetic Testing And Evaluation) and BXB (Exerciser, Powered). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Loredan Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Loredan Biomedical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?