FDA applicant
Axora Medical, Inc.
FDA records 3 decisions for Axora Medical, Inc. (Jacksonville) from 2001 to 2026: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes MNB (Device, Thermal Ablation, Endometrial) and HIH (Hysteroscope (And Accessories)). Its devices cite 2 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Axora Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
2in 2009
Class I Class II/III not classified
Planning a device like Axora Medical, 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) Report