FDA applicant

Hart Enterprises, Inc.

Wyoming, MI4 decisions1988–19930 recalls

FDA records 4 decisions for Hart Enterprises, Inc. (Wyoming, MI) from 1988 to 1993: 4 510(k) clearances. Most are in product codes DWO (Needle, Biopsy, Cardiovascular) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). 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 Hart Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hart Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hart Enterprises, Inc.

Which product codes does it file in?

What has FDA decided for it lately?