510(k) Report

FDA applicant

Singer Medical Products, Inc.

Bensenville, IL8 decisions1989–19910 recalls

FDA records 8 decisions for Singer Medical Products, Inc. (Bensenville, IL) from 1989 to 1991: 8 510(k) clearances. Most are in product codes EWO (Audiometer) and BXN (Stimulator, Nerve, 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 Singer Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Singer Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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