Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAXONICS MODULATION TECHNOLOGIES, INC.
US
Last updated May 24, 2026
What AXONICS MODULATION TECHNOLOGIES, INC. makes
The company manufactures synthetic polymer materials for urinary tract reconstruction, including non-bioabsorbable implants like Bulkamid. It also produces sacral plexus-based electrical stimulation systems for incontinence control, including implantable and percutaneous electrode devices, as well as rechargeable implant batteries and line-powered programmers. Additional products include single-use medical cables, reusable personal device holders, and disposable measurement tools like medical rulers.
All listed devices fall under Class III regulatory classification in the U.S., requiring premarket approval (PMA) or exemptions. The company’s products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. The manufacturer is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- axonics.com
- —
- —
- [email protected]
- Phone
- +1 (877) 929-6642
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079562449
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Axonics | 4101 | FDA UDI | Class III | Active |
| Axonics | 1401 | FDA UDI | Class III | Active |
| Axonics | 1401 | FDA UDI | Class III | Active |
| Axonics | 5101 | FDA UDI | Class III | Active |
| Axonics | FFG-01 | FDA UDI | Class III | Active |
| Axonics | 9108-R | FDA UDI | Class III | Active |
| Bulkamid | 50050 | FDA UDI | Class III | Active |
| Axonics | 9015 | FDA UDI | Class III | Active |
| Axonics | 9108-E | FDA UDI | Class III | Active |
| Axonics | 9009 | FDA UDI | Class III | Active |
| Bulkamid | 60030 | FDA UDI | Class III | Active |
| Axonics | 1501 | FDA UDI | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Axionics Modulation Technologies, Inc. has one FDA recall record initiated on June 3, 2021, which is marked as terminated. The recall was due to a potential lack of sterility assurance, specifically noting that a needle in a procedure pack labeled as sterile may not have been adequately sterilized.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 3, 2021 | Z-2077-2021 | — | terminated | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized |