FDA Registration
Active
🇺🇸 United States
AXORA MEDICAL, INC.
Reg #: 3043236281
·
FEI: 3043236281
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- AXORA MEDICAL, INC.
- Registration Number
- 3043236281
- FEI Number
- 3043236281
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 Independent Dr
- City
- Jacksonville
- State
- FL
- ZIP
- 32202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141848
- PMA Number
- P000040
Owner / Operator
- Firm Name
- Axora Medical, Inc.
- Operator Number
- 10095231
- Address
- 1 Independent Drive
- City
- Jacksonville
- State
- FL
- Postal Code
- 32202
- Country
- US
- Correspondent
- Natalie Kennel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | PGT | Class 2 | Obstetrics/Gynecology | No | 2026-02-20 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2026-02-21 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2026-02-21 |
| Device, Thermal Ablation, Endometrial | MNB | Class 3 | Unknown | No | 2026-02-21 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2026-02-09 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2026-02-21 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2026-02-21 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility