Data / Medical devices / Suture, Surgical, Absorbable, Polydioxanone / United States
FDA-registered makers of Suture, Surgical, Absorbable, Polydioxanone in the United States: 18 establishments
18 establishments in the United States are registered with the FDA to make Suture, Surgical, Absorbable, Polydioxanone (product code NEW). 16 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Suture, Surgical, Absorbable, Polydioxanone
- Product code
- NEW
- Country
- United States
Makers of Suture, Surgical, Absorbable, Polydioxanone in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | San Angelo, TX, United States | Manufacturer | 6 | May 18, 2026 | 1 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer, Specification developer | 6 | May 18, 2026 | 1 | 2 | 0 | api.fda.gov |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 6 | May 18, 2026 | 1 | 2 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 4 | February 22, 2022 | 1 | 9 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 4 | February 26, 2013 | 0 | 1 | 0 | api.fda.gov |
| Demetech Corp. | Miami Lakes, FL, United States | Manufacturer | 3 | November 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Kollsut International Inc | North Miami Beach, FL, United States | Manufacturer | 3 | October 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC. | San Lorenzo, PR, United States | Manufacturer | 2 | March 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Pdo Max | Liverpool, NY, United States | Specification developer | 2 | December 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Bella Tech Global Inc | Brea, CA, United States | Specification developer | 1 | August 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Manufacturer | 1 | May 23, 2012 | 0 | 0 | 0 | api.fda.gov |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 1 | June 18, 2003 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Manufacturer | 1 | July 8, 2010 | 0 | 1 | 0 | api.fda.gov |
| Senzime Inc. | Saint Louis, MO, United States | Specification developer | 1 | April 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sutura Medical Technologies LLC | Miami, FL, United States | Specification developer | 1 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer | 1 | March 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| Cypris Medical, Inc. | Evanston, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Fibers OEM LLC | Mansfield, MA, 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.