Data / Medical devices / Suture, Nonabsorbable, Synthetic, Polyethylene / United States
FDA-registered makers of Suture, Nonabsorbable, Synthetic, Polyethylene in the United States: 73 establishments
73 establishments in the United States are registered with the FDA to make Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT). 39 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, Nonabsorbable, Synthetic, Polyethylene
- Product code
- GAT
- Country
- United States
Makers of Suture, Nonabsorbable, Synthetic, Polyethylene in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 18 | May 6, 2026 | 0 | 2 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Manufacturer, Specification developer | 14 | October 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 14 | March 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer, Specification developer | 13 | February 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 11 | February 1, 2021 | 0 | 2 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Manufacturer, Specification developer | 9 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer, Repackager or relabeler, Specification developer | 6 | November 10, 2010 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer, Repackager or relabeler | 6 | January 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 5 | April 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Threadstone LLC | Millersville, MD, United States | Complaint file establishment, Manufacturer | 5 | March 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 4 | January 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| ArthroCare Corporation | Austin, TX, United States | Specification developer | 4 | January 6, 2017 | 0 | 1 | 0 | api.fda.gov |
| Dunamis Medical LLC | Greenville, AL, United States | Manufacturer, Specification developer | 4 | March 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | May 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer | 3 | November 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 3 | September 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| AtriCure, Inc. | Pleasanton, CA, United States | Specification developer | 3 | November 25, 2015 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 3 | February 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 3 | October 30, 2013 | 0 | 0 | 0 | api.fda.gov |
| Allosource | Centennial, CO, United States | Manufacturer | 2 | June 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Demetech Corp. | Miami Lakes, FL, United States | Manufacturer | 2 | July 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Manufacturer | 2 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | Greenwood Village, CO, United States | Specification developer | 2 | November 10, 2016 | 0 | 0 | 0 | api.fda.gov |
| Winter Innovations, Inc. | Eden Prairie, MN, United States | Complaint file establishment, Specification developer | 2 | July 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cayenne Medical, Inc. | Scottsdale, AZ, United States | Manufacturer | 1 | June 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Embody, Inc. | Norfolk, VA, United States | Manufacturer | 1 | June 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Implicitcare, LLC | Newport Beach, CA, United States | Manufacturer | 1 | November 13, 2009 | 0 | 0 | 0 | api.fda.gov |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 1 | March 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 1 | May 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 1 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Olyphant, PA, United States | Manufacturer | 1 | March 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Edison, NJ, United States | Manufacturer | 1 | March 15, 2019 | 0 | 1 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Jessup, PA, United States | Manufacturer | 1 | March 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 1 | August 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Specification developer | 1 | May 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| Usgi Medical | San Clemente, CA, United States | Manufacturer | 1 | October 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 1 | August 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 1 | August 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Neuromodulation Corporation | Valencia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Confluent Medical Technologies, Inc. | Warwick, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Community Blood Center dba Solvita | Kettering, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eagle Medical Packaging Sterilization, Inc. | Paso Robles, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endeavor Orthopaedics, Inc. | Tulsa, OK, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, LLC. | San Lorenzo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon LLC | Manati, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Janco, Inc. | Rollinsford, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kollsut International Inc | North Miami Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifenet Health | Virginia Beach, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linemaster Switch Corp. | Woodstock, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Virginia Bch, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Plainfield, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health Northwest | Renton, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medshape, Inc. | Atlanta, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ORIGAMI SURGICAL Inc. | Dover, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parcus Medical, L.L.C. | Sarasota, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Medical Products, Inc. | Mountain City, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Fibers OEM LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, 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 | |
| Trilliant Surgical LLC | Houston, TX, 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.