FDA applicant
Certified Safety Mfg., Inc.
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
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
Class I Class II/III not classified
Planning a device like Certified Safety Mfg., 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) ReportOther applicant names beginning “Certified”
FDA records each applicant name separately; these may or may not be the same firm.