FDA applicant
Theramicro
FDA records 5 decisions for Theramicro (Cordova, TN) from 2025 to 2026: 5 510(k) clearances. Most are in product codes QUW (Mesh, Surgical, Non-Resorbable, Orthopedics…) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 12 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “TheraMicro”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Theramicro’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Theramicro’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