# Axora Medical, Inc.

- Location (FDA's records): Jacksonville
- FDA decisions: 3 (2001–2026): 1 510(k) clearance and 2 original PMA approvals
- Product codes: MNB (2), HIH (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Caldera Medical, Inc.: 1 (https://510kreport.com/company/caldera-medical)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Recent decisions
- K260984: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) (Aug 18, 2026)
- P140013: Minerva Endometrial Ablation System (Jul 27, 2015)
- P000040: Hydro Thermablator Endometrial Ablation System (Apr 20, 2001)

Source page: https://510kreport.com/company/axora-medical