FDA applicant

Osteon, Inc.

Wahiawa, HI2 decisions1985–19890 recalls

FDA records 2 decisions for Osteon, Inc. (Wahiawa, HI) from 1985 to 1989: 2 510(k) clearances. All are in product code KGI (Densitometer, Bone). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Osteon, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Osteon, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?