FDA applicant

Dyonics, Inc.

Andover, MA19 decisions1978–19900 recalls

FDA records 19 decisions for Dyonics, Inc. (Andover, MA) from 1978 to 1990: 19 510(k) clearances. Most are in product codes HRX (Arthroscope) and KIJ (Instrument, Surgical, Orthopedic, Dc-Powered…). Its devices cite 2 predicates, 2 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Dyonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Dyonics, 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?