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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer18May 6, 2026020api.fda.gov
Arthrex, Inc.Naples, FL, United StatesManufacturer, Specification developer14October 27, 2022000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler14March 30, 2020000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer13February 1, 2021000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer11February 1, 2021020api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer, Specification developer9October 16, 2025000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Repackager or relabeler, Specification developer6November 10, 2010010api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler6January 6, 2017000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer5April 26, 2022000api.fda.gov
Threadstone LLCMillersville, MD, United StatesComplaint file establishment, Manufacturer5March 23, 2026000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer4January 30, 2014000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer4January 6, 2017010api.fda.gov
Dunamis Medical LLCGreenville, AL, United StatesManufacturer, Specification developer4March 30, 2020000api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Specification developer4May 13, 2022000api.fda.gov
Atricure, Inc.Mason, OH, United StatesComplaint file establishment, Manufacturer3November 25, 2015000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer3September 25, 2012000api.fda.gov
AtriCure, Inc.Pleasanton, CA, United StatesSpecification developer3November 25, 2015000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer3February 17, 2017000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer3October 30, 2013000api.fda.gov
AllosourceCentennial, CO, United StatesManufacturer2June 27, 2023000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer2July 31, 2019000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesManufacturer2October 22, 2025000api.fda.gov
Stryker EndoscopyGreenwood Village, CO, United StatesSpecification developer2November 10, 2016000api.fda.gov
Winter Innovations, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Specification developer2July 1, 2026000api.fda.gov
Cayenne Medical, Inc.Scottsdale, AZ, United StatesManufacturer1June 4, 2012000api.fda.gov
Embody, Inc.Norfolk, VA, United StatesManufacturer1June 2, 2023000api.fda.gov
Implicitcare, LLCNewport Beach, CA, United StatesManufacturer1November 13, 2009000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer1March 1, 2004000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer1May 21, 2013000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer1October 29, 2015000api.fda.gov
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsOlyphant, PA, United StatesManufacturer1March 15, 2019000api.fda.gov
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsEdison, NJ, United StatesManufacturer1March 15, 2019010api.fda.gov
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsJessup, PA, United StatesManufacturer1March 15, 2019000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1July 14, 2016000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer1August 13, 2015000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesSpecification developer1May 10, 2010000api.fda.gov
Usgi MedicalSan Clemente, CA, United StatesManufacturer1October 20, 2010000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer1August 22, 2017000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer1August 22, 2017000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer0000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Boston Scientific Neuromodulation CorporationValencia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Confluent Medical Technologies, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Community Blood Center dba SolvitaKettering, OH, United StatesContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Eagle Medical Packaging Sterilization, Inc.Paso Robles, CA, United StatesContract manufacturer0000api.fda.gov
Endeavor Orthopaedics, Inc.Tulsa, OK, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer0000api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesManufacturer0000api.fda.gov
Ethicon, LLCGuaynabo, PR, United StatesManufacturer0000api.fda.gov
Ethicon, LLC.San Lorenzo, PR, United StatesManufacturer0000api.fda.gov
Ethicon LLCManati, PR, United StatesManufacturer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer0000api.fda.gov
Kollsut International IncNorth Miami Beach, FL, United StatesManufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Lifenet HealthVirginia Beach, VA, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthVirginia Bch, VA, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthPlainfield, IN, United StatesContract manufacturer0000api.fda.gov
LifeNet Health NorthwestRenton, WA, United StatesContract manufacturer0000api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer0000api.fda.gov
ORIGAMI SURGICAL Inc.Dover, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Performance Fibers OEM LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.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.