Data / Medical devices / Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene / United States
FDA-registered makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Product code
- NBY
- Country
- United States
Makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Antarma LLC | New York, NY, United States | Complaint file establishment, Specification developer | 2 | September 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | March 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Demetech Corp. | Miami Lakes, FL, United States | Manufacturer | 1 | October 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| DuraStat | Austin, TX, United States | Manufacturer, Specification developer | 1 | February 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Kollsut International Inc | North Miami Beach, FL, United States | Manufacturer | 1 | July 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 1 | June 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| ORIGAMI SURGICAL Inc. | Dover, MA, United States | Complaint file establishment, Specification developer | 1 | September 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 1 | October 31, 2007 | 0 | 0 | 0 | api.fda.gov |
| Cypris Medical, Inc. | Evanston, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Sterling Industries LLC | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roechling Medical Lancaster, LLC | Denver, PA, United States | 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.