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Data / Medical devices / Suture, Nonabsorbable, Synthetic, Polyamide

Suture, Nonabsorbable, Synthetic, Polyamide (GAR): 55 FDA-registered makers in 17 countries

55 establishments in 17 countries are registered with the FDA to make Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR, Class 2, 21 CFR 878.5020). 30 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 57 510(k) clearances under this code, the latest on June 3, 2026, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
GAR
Device class
2
Regulation
878.5020
Medical specialty
General, Plastic Surgery
Implant
Yes

Makers by country

CountryMakers
United States23
Mexico6
India5
Japan4
China3
Vietnam2
Germany2
Dominican Republic1
France1
South Korea1
Peru1
Saudi Arabia1
Ukraine1
Guatemala1
Nicaragua1
Thailand1
Czechia1

Makers of Suture, Nonabsorbable, Synthetic, Polyamide

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
S. Jackson, Inc.Alexandria, VA, United StatesManufacturer4December 17, 1993100api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Specification developer2July 13, 1998020api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer2July 13, 1998000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer, Specification developer2October 28, 2015010api.fda.gov
Tas Medical, Inc.Windermere, FL, United StatesComplaint file establishment, Specification developer2June 3, 2026010api.fda.gov
Antarma LLCNew York, NY, United StatesComplaint file establishment, Specification developer1March 31, 2022000api.fda.gov
Arc Medical Supplies (beijing) Co, Ltd.Beijing, ChinaManufacturer1April 27, 2000000api.fda.gov
Aros Surgical Instruments CorporationNorth Wales, PA, United StatesSpecification developer1October 14, 2004000api.fda.gov
AurolabMADURAI Tamil Nadu, IndiaContract manufacturer, Manufacturer1February 28, 2003000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer1December 17, 1993000api.fda.gov
Bear Medic CorporationDaigomachi, Kuji-gun Ibaraki, JapanManufacturer1October 14, 2004000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesManufacturer1June 18, 2003000api.fda.gov
Healthium Medtech LimitedBANGALORE Karnataka, IndiaManufacturer1June 2, 2005000api.fda.gov
Healthium Medtech LimitedSRI CITY Andhra Pradesh, IndiaManufacturer1June 2, 2005000api.fda.gov
Internacional Farmaceutica, S.A. De C.V.Mexico City, MexicoManufacturer1February 11, 1991000api.fda.gov
Internacional Farmaceutica, S.A. De C.V.LERMA Mexico, MexicoManufacturer1February 11, 1991000api.fda.gov
Keisei Medical Industrial Co., Ltd.BUNKYO-KU Tokyo, JapanManufacturer1March 30, 2000000api.fda.gov
Kono SeisakushoIchikawa Chiba, JapanComplaint file establishment, Manufacturer1May 29, 2020000api.fda.gov
Mani, Inc. (head Office)UTSUNOMIYA Tochigi, JapanManufacturer1May 19, 2006000api.fda.gov
Nashville Surgical InstrumentsSpringfield, TN, United StatesSpecification developer1July 15, 2008000api.fda.gov
Orion Sutures (india) Private LimitedBENGALURU Karnataka, IndiaManufacturer1July 21, 2003000api.fda.gov
Peters SurgicalBOULOGNE-BILLANCOURT Hauts-de-Seine, FranceExporter to the US, Specification developer1August 3, 1992000api.fda.gov
Shandong Haidike Medical Products Co., LtdHeze Shandong, ChinaManufacturer1December 22, 2021000api.fda.gov
Smeng Co.,ltd.Busan, South KoreaManufacturer1March 2, 2017000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesSpecification developer1October 28, 2015000api.fda.gov
Surgical Specialties Mexico S DE RL DE CVTijuana Baja California, MexicoManufacturer1October 25, 1990000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1July 7, 1998010api.fda.gov
Unilene, SacLima Lima(Region), PeruManufacturer1May 28, 2013000api.fda.gov
United Medical Industries Co. Ltd.RIYADH Ar Riyad, Saudi ArabiaManufacturer1December 3, 2004000api.fda.gov
Visionary Medical Supplies, Inc.Madison, WI, United StatesManufacturer1February 8, 2000000api.fda.gov
Ethicon, Inc.CIUDAD JUAREZ Chihuahua, MexicoManufacturer0000api.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 StatesManufacturer, Manufacturer for export0000api.fda.gov
Ethicon LLCManati, PR, United StatesManufacturer0000api.fda.gov
Foosin Medical Supplies Inc.ltdWEIHAI Shandong, ChinaManufacturer0000api.fda.gov
Golnit LtdKiev Kyyiv, Misto, UkraineContract manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Kollsut International IncNorth Miami Beach, FL, United StatesManufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Medisut, S.A.Managua, NicaraguaContract manufacturer0000api.fda.gov
Meril Endo Surgery Pvt. Ltd.Vapi Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Mani Hanoi Co. LtdThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
Mani Hanoi Co. Ltd Pho Yen 2 FactoryThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
Medizin Produkte Neustadt GmbH (MPN)Neustadt in Holstein Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Peters Surgical International Co., LtdBangkok Krung Thep Maha Nakhon, ThailandContract manufacturer, Contract sterilizer0000api.fda.gov
Performance Fibers OEM LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
RESORBA Medical GmbHNUERNBERG Bavaria, GermanyManufacturer0000api.fda.gov
Resorba, s.r.oDomazlice, CzechiaManufacturer0000api.fda.gov
Sharp Fluidics, Inc.El Granada, CA, United StatesSpecification developer0000api.fda.gov
Sirius Engineering LLCSan Carlos, CA, United StatesContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov

Updated June 3, 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.