Data / Medical devices / Agent, Bulking, Injectable For Gastro-Urology Use
Agent, Bulking, Injectable For Gastro-Urology Use (LNM): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Agent, Bulking, Injectable For Gastro-Urology Use (product code LNM, Class 3). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LNM
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Sweden | 2 |
| Denmark | 1 |
| Germany | 1 |
Makers of Agent, Bulking, Injectable For Gastro-Urology Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Bio-Hospital AB | KOPPARBERG Orebro, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contura International A/S | Soeborg Hovedstaden, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moeller Medical GMBH | FULDA Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Q-Med AB | Uppsala, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.