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Data / Medical devices / Suture, Absorbable, Synthetic, Polyglycolic Acid / United States

FDA-registered makers of Suture, Absorbable, Synthetic, Polyglycolic Acid in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM). 16 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Suture, Absorbable, Synthetic, Polyglycolic Acid
Product code
GAM
Country
United States

Makers of Suture, Absorbable, Synthetic, Polyglycolic Acid in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienNorth Haven, CT, United StatesManufacturer, Repackager or relabeler, Specification developer12May 28, 2026050api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesManufacturer, Specification developer12February 6, 2026030api.fda.gov
Ethicon, LLCGuaynabo, PR, United StatesManufacturer12February 6, 2026000api.fda.gov
Ethicon, Inc.San Angelo, TX, United StatesManufacturer11February 6, 2026000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer10November 15, 20220110api.fda.gov
Kollsut International IncNorth Miami Beach, FL, United StatesManufacturer5January 28, 2019000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler5May 17, 2006000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer4May 17, 2006040api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer3May 30, 2014000api.fda.gov
Ethicon, LLC.San Lorenzo, PR, United StatesManufacturer3December 22, 2025000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer3June 3, 2011000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer, Specification developer3May 23, 2012020api.fda.gov
Sinclair Pharma Us, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer3March 27, 2020010api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesManufacturer2April 19, 2006000api.fda.gov
ORIGAMI SURGICAL Inc.Dover, MA, United StatesComplaint file establishment, Specification developer1July 16, 2021000api.fda.gov
Visionary Medical Supplies, Inc.Madison, WI, United StatesManufacturer1February 3, 2011000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Coloplast Manufacturing Us, LLCMinneapolis, MN, United StatesManufacturer0010api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Ethicon LLCManati, PR, United StatesManufacturer0000api.fda.gov
Isomedix Operations Inc.Whippany, NJ, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations Inc.Chester, NY, United StatesManufacturer for export0000api.fda.gov
Isomedix Operations, Inc.Minneapolis, MN, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Performance Fibers OEM LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer, Manufacturer for export0000api.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.