510(k) Report

FDA applicant

Certified Safety Mfg., Inc.

Kansas City, MO17 decisions1994–19972 recalls

FDA records 17 decisions for Certified Safety Mfg., Inc. (Kansas City, MO) from 1994 to 1997: 17 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and IMD (Pack, Hot Or Cold, Disposable). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Certified Safety Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Certified Safety Mfg., Inc. since 2007.

Recalls per year

1in 2022

2018: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Certified Safety Mfg., 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 “Certified”

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