510(k) Report

FDA applicant

Stuart Medical, Inc.

North Attleboro, MA2 decisions1985–19920 recalls

FDA records 2 decisions for Stuart Medical, Inc. (North Attleboro, MA) from 1985 to 1992: 2 510(k) clearances. Most are in product codes LOS (Unnamed device) and JAK (System, X-Ray, Tomography, Computed). 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, radiology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stuart 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 “Stuart”

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