FDA applicant
Medtec Inc. Dba Civco Medical Solutions
FDA records 2 decisions for Medtec Inc. Dba Civco Medical Solutions (Orange City, IA) from 2012 to 2018: 2 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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. Dba Civco Medical Solutions’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Medtec Inc. Dba Civco Medical Solutions’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.