FDA applicant
American Midwest
FDA records 5 decisions for American Midwest (Mchenry, IL) from 1980 to 1982: 5 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EFB (Handpiece, Air-Powered, Dental). 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 American Midwest’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Midwest since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Midwest’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) Report