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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI, United StatesComplaint file establishment, Specification developer20June 12, 20250130api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer12August 6, 2020030api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesManufacturer, Specification developer12August 6, 2020000api.fda.gov
W. L. Gore & Associates, Inc.Elkton, MD, United StatesManufacturer7May 11, 2017010api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesManufacturer for export, Specification developer6April 8, 2020000api.fda.gov
Medtronic, Inc.Minneapolis, MN, United StatesManufacturer, Manufacturer for export6April 8, 2020000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer5December 6, 2019000api.fda.gov
Chamberlain Technologies, LLCDeer Park, IL, United StatesSpecification developer4June 26, 2012010api.fda.gov
Boylston Surgical LLCOsterville, MA, United StatesSpecification developer3August 6, 2014000api.fda.gov
Ethicon, Inc.San Angelo, TX, United StatesManufacturer3August 6, 2020000api.fda.gov
Mast Biosurgery Usa Inc.San Diego, CA, United StatesManufacturer3January 7, 2021010api.fda.gov
Tela Bio, Inc.Malvern, PA, United StatesComplaint file establishment, Manufacturer, Specification developer3September 28, 2026000api.fda.gov
Ethicon, LLC.San Lorenzo, PR, United StatesManufacturer2June 28, 2018000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer2January 15, 2009000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesManufacturer2January 15, 2009000api.fda.gov
Cook Biotech, Inc.West Lafayette, IN, United StatesManufacturer1October 13, 2006000api.fda.gov
Deep Blue Medical Advances, Inc.Durham, NC, United StatesSpecification developer1March 30, 2020000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer1July 26, 2006000api.fda.gov
Implantech Associates, Inc.Ventura, CA, United StatesManufacturer1August 31, 2007000api.fda.gov
Kollsut International IncNorth Miami Beach, FL, United StatesManufacturer1July 26, 2006000api.fda.gov
Preservation Solutions, Inc.Elkhorn, WI, United StatesContract manufacturer, Manufacturer1November 18, 1999000api.fda.gov
Specialty Surgical Products, Inc.Victor, MT, United StatesComplaint file establishment, Specification developer1November 4, 1997000api.fda.gov
Surgical Innovation Associates, Inc.Chicago, IL, United StatesSpecification developer1August 2, 2018000api.fda.gov
Technical Products, Inc.Buford, GA, United StatesManufacturer, Repackager or relabeler1July 1, 1997000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
ArtelonAtl, GA, United StatesManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationRoswell, GA, United StatesManufacturer, Specification developer0000api.fda.gov
Celestray Biotech Company, LLC.Bethesda, MD, United StatesSpecification developer0000api.fda.gov
ConMed CorporationNew Haven, CT, United StatesSpecification developer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Genadyne Biotechnologies, Inc.Hicksville, NY, United StatesSpecification developer0000api.fda.gov
Grant Technologies LLCLake Zurich, IL, United StatesContract manufacturer0000api.fda.gov
Genadyne Biotechnologies, Inc.Bohemia, NY, United StatesManufacturer0000api.fda.gov
International Life SciencesSandy Springs, GA, United StatesSpecification developer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer0000api.fda.gov
Poly-Med, Inc.Anderson, SC, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
SSP-SiMatrix Inc.Victor, MT, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
TheramicroCordova, TN, United StatesSpecification developer0000api.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.