FDA applicant

Trace Medical Equipment, Inc.

Lisle, IL2 decisions1993–19930 recalls

FDA records 2 decisions for Trace Medical Equipment, Inc. (Lisle, IL) in 1993: 2 510(k) clearances. Most are in product codes FYH (Splint, Extremity, Noninflatable, External…) and KMK (Device, Intravascular Catheter Securement). 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 Trace Medical Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Trace Medical Equipment, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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See the 510(k) Report

Other applicant names beginning “Trace”

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

Trace Scientific, Ltd. 55 Trace America, Inc. 22 Trace Analytical 1

Trace Medical Equipment, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Trace”