510(k) Report

FDA applicant

Stanton Magnetics, Inc.

Plainview, NY1 decision1990–19900 recalls

FDA records 1 decision for Stanton Magnetics, Inc. (Plainview, NY) in 1990: 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 Stanton Magnetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stanton Magnetics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stanton Magnetics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report