510(k) Report

FDA applicant

Bruce Medical Supply

Waltham, MA1 decision1993–19930 recalls

FDA records 1 decision for Bruce Medical Supply (Waltham, MA) in 1993: 1 510(k) clearance. All are in product code ESE (Larynx, Artificial (Battery-Powered)). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Bruce Medical Supply since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bruce”

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