FDA applicant
Miltex, Inc.
FDA records 23 decisions for Miltex, Inc. (Mchenry, IL) from 1982 to 2010: 23 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and EKS (File, Pulp Canal, Endodontic). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Miltex, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Miltex, 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 “Miltex”
FDA records each applicant name separately; these may or may not be the same firm.