Data / Medical devices / Agent, Bulking, Injectable For Gastro-Urology Use / United States
FDA-registered makers of Agent, Bulking, Injectable For Gastro-Urology Use in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Agent, Bulking, Injectable For Gastro-Urology Use (product code LNM). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Agent, Bulking, Injectable For Gastro-Urology Use
- Product code
- LNM
- Country
- United States
Makers of Agent, Bulking, Injectable For Gastro-Urology Use in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Palette Life Sciences | Santa Barbara, CA, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Axonics, Inc. | Irvine, CA, United States | Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Carbon Medical Technologies, Inc. | Saint Paul, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Merz North America, Inc. | Sturtevant, WI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Merz North America, Inc. | Franksville, WI, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Uroplasty, LLC | Minnetonka, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.