FDA applicant

Biotrac Laboratories

Walker, MI2 decisions1983–19840 recalls

FDA records 2 decisions for Biotrac Laboratories (Walker, MI) from 1983 to 1984: 2 510(k) clearances. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and GAD (Retractor). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Biotrac Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Biotrac”

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

Biotrac, Inc. 1

Biotrac Laboratories

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotrac”