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Data / Medical devices / Suture, Absorbable, Natural / United States

FDA-registered makers of Suture, Absorbable, Natural in the United States: 12 establishments

12 establishments in the United States are registered with the FDA to make Suture, Absorbable, Natural (product code GAL). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Suture, Absorbable, Natural
Product code
GAL
Country
United States

Makers of Suture, Absorbable, Natural in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer3December 17, 1993010api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer1April 30, 2008000api.fda.gov
Kollsut International IncNorth Miami Beach, FL, United StatesManufacturer, Specification developer1September 7, 2005000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer1December 24, 1990000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1July 26, 1994000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1July 26, 1994000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer0010api.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
Performance Fibers OEM LLCMansfield, MA, 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.