510(k) Report

FDA applicant

Safety-Med Products, Inc.

Burlington, WI1 decision2004–20040 recalls

FDA records 1 decision for Safety-Med Products, Inc. (Burlington, WI) in 2004: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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 Safety-Med Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safety-Med Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Safety-Med 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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Other applicant names beginning “Safety-Med”

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