Bulkamid 60030
by Axonics Modulation Technologies, Inc.
Bulkamid 60030 is a Class III device made by Axonics Modulation Technologies, Inc., listed in FDA GUDID since 30 Aug 2023 (UDI-DI 10810005340493), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10810005340493 | Date30 Aug 2023 | StatusListed |
Official records
- AccessGUDID record 10810005340493
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Bulkamid
- Generic name
- Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
- Model / reference
- 60030
- Primary DI / UDI-DI
- 10810005340493
- FDA product code
- LNM
- GMDN term
- Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LNM (Agent, Bulking, Injectable For Gastro-Urology Use).
- Bard URYX Urethral Bulking Agent by C. R. Bard, Inc.
- Macroplastique Implants by Uroplasty, LLC
- Solesta Injectable Gel by Palette Life Sciences Inc.
- Contigen Bard Collagen Implant by Allergan
- Deflux Injectable Gel by Palette Life Sciences Inc.
- Bulkamid Urethral Bulking System by Boston Scientific
- Durasphere Injectable Bulking Agent by Carbon Medical Technologies, Inc.
- Enteryx Procedure Kit by Boston Scientific
- Coaptite Injectable Implant by Merz North America, Inc.
Other devices from Axonics Modulation Technologies, Inc.
See all devices from Axonics Modulation Technologies, Inc. →