FDA applicant

Trimedyne, Inc.

Irvine, CA60 decisions1981–20050 recalls

FDA records 60 decisions for Trimedyne, Inc. (Irvine, CA) from 1981 to 2005: 58 510(k) clearances and 2 original PMA approvals. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNK (Laser For Gastro-Urology Use). Its devices cite 15 predicates, 11 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Trimedyne, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Trimedyne, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?