FDA applicant

Treace Medical, Inc.

Mchenry, IL80 decisions1982–19890 recalls

FDA records 80 decisions for Treace Medical, Inc. (Mchenry, IL) from 1982 to 1989: 80 510(k) clearances. Most are in product codes ETD (Tube, Tympanostomy) and ETB (Prosthesis, Partial Ossicular Replacement). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Treace Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Treace”

FDA records each applicant name separately; these may or may not be the same firm.

Treace Medical Concepts, Inc. 21

Treace Medical, 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?

Other applicant names beginning “Treace”