FDA applicant

The Traumafuse Co.

Allentown, PA4 decisions1989–19900 recalls

FDA records 4 decisions for The Traumafuse Co. (Allentown, PA) from 1989 to 1990: 4 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). 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, anesthesiology panel, where it files most

How often FDA has decided The Traumafuse Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Traumafuse Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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The Traumafuse Co.

Which product codes does it file in?

What has FDA decided for it lately?