Data / Medical devices / Mesh, Surgical, Polymeric / United States
FDA-registered makers of Mesh, Surgical, Polymeric in the United States: 50 establishments
50 establishments in the United States are registered with the FDA to make Mesh, Surgical, Polymeric (product code FTL). 24 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
- Mesh, Surgical, Polymeric
- Product code
- FTL
- Country
- United States
Makers of Mesh, Surgical, Polymeric in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 20 | June 12, 2025 | 0 | 13 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 12 | August 6, 2020 | 0 | 3 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer, Specification developer | 12 | August 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc. | Elkton, MD, United States | Manufacturer | 7 | May 11, 2017 | 0 | 1 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer for export, Specification developer | 6 | April 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Minneapolis, MN, United States | Manufacturer, Manufacturer for export | 6 | April 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 5 | December 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Chamberlain Technologies, LLC | Deer Park, IL, United States | Specification developer | 4 | June 26, 2012 | 0 | 1 | 0 | api.fda.gov |
| Boylston Surgical LLC | Osterville, MA, United States | Specification developer | 3 | August 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | San Angelo, TX, United States | Manufacturer | 3 | August 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Mast Biosurgery Usa Inc. | San Diego, CA, United States | Manufacturer | 3 | January 7, 2021 | 0 | 1 | 0 | api.fda.gov |
| Tela Bio, Inc. | Malvern, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC. | San Lorenzo, PR, United States | Manufacturer | 2 | June 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 2 | January 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer | 2 | January 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 1 | October 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Deep Blue Medical Advances, Inc. | Durham, NC, United States | Specification developer | 1 | March 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Demetech Corp. | Miami Lakes, FL, United States | Manufacturer | 1 | July 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Implantech Associates, Inc. | Ventura, CA, United States | Manufacturer | 1 | August 31, 2007 | 0 | 0 | 0 | api.fda.gov |
| Kollsut International Inc | North Miami Beach, FL, United States | Manufacturer | 1 | July 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Preservation Solutions, Inc. | Elkhorn, WI, United States | Contract manufacturer, Manufacturer | 1 | November 18, 1999 | 0 | 0 | 0 | api.fda.gov |
| Specialty Surgical Products, Inc. | Victor, MT, United States | Complaint file establishment, Specification developer | 1 | November 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Surgical Innovation Associates, Inc. | Chicago, IL, United States | Specification developer | 1 | August 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Technical Products, Inc. | Buford, GA, United States | Manufacturer, Repackager or relabeler | 1 | July 1, 1997 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Artelon | Atl, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 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 | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Roswell, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Celestray Biotech Company, LLC. | Bethesda, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConMed Corporation | New Haven, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genadyne Biotechnologies, Inc. | Hicksville, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grant Technologies LLC | Lake Zurich, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genadyne Biotechnologies, Inc. | Bohemia, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| International Life Sciences | Sandy Springs, GA, United States | Specification developer | 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 | |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poly-Med, Inc. | Anderson, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, 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 | |
| SSP-SiMatrix Inc. | Victor, MT, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theramicro | Cordova, TN, United States | Specification developer | 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.