Data / Medical devices / Mesh, Surgical, For Stress Urinary Incontinence, Male / United States
FDA-registered makers of Mesh, Surgical, For Stress Urinary Incontinence, Male in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Mesh, Surgical, For Stress Urinary Incontinence, Male
- Product code
- OTM
- Country
- United States
Makers of Mesh, Surgical, For Stress Urinary Incontinence, Male in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 2 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer, Manufacturer for export | 2 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Manufacturer | 2 | September 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | December 20, 2021 | 0 | 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.