FDA applicant
Medtec, Inc.
FDA records 41 decisions for Medtec, Inc. (Orange City, IA) from 1993 to 2014: 41 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IWE (Monitor, Patient Position, Light-Beam). Its devices cite 8 predicates, 4 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtec, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Medtec, 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 “Medtec”
FDA records each applicant name separately; these may or may not be the same firm.