FDA applicant
Orthomedics
FDA records 16 decisions for Orthomedics (Mchenry, IL) from 1980 to 1983: 16 510(k) clearances. Most are in product codes IQI (Orthosis, Limb Brace) and IQF (Orthosis, Cervical-Thoracic, Rigid). 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 Orthomedics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Orthomedics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orthomedics’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