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.
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- Product code
- GAR
- Device class
- 2
- Regulation
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 23 |
| Mexico | 6 |
| India | 5 |
| Japan | 4 |
| China | 3 |
| Vietnam | 2 |
| Germany | 2 |
| Dominican Republic | 1 |
| France | 1 |
| South Korea | 1 |
| Peru | 1 |
| Saudi Arabia | 1 |
| Ukraine | 1 |
| Guatemala | 1 |
| Nicaragua | 1 |
| Thailand | 1 |
| Czechia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| S. Jackson, Inc. | Alexandria, VA, United States | Manufacturer | 4 | December 17, 1993 | 1 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer, Specification developer | 2 | July 13, 1998 | 0 | 2 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Manufacturer | 2 | July 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | October 28, 2015 | 0 | 1 | 0 | api.fda.gov |
| Tas Medical, Inc. | Windermere, FL, United States | Complaint file establishment, Specification developer | 2 | June 3, 2026 | 0 | 1 | 0 | api.fda.gov |
| Antarma LLC | New York, NY, United States | Complaint file establishment, Specification developer | 1 | March 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Arc Medical Supplies (beijing) Co, Ltd. | Beijing, China | Manufacturer | 1 | April 27, 2000 | 0 | 0 | 0 | api.fda.gov |
| Aros Surgical Instruments Corporation | North Wales, PA, United States | Specification developer | 1 | October 14, 2004 | 0 | 0 | 0 | api.fda.gov |
| Aurolab | MADURAI Tamil Nadu, India | Contract manufacturer, Manufacturer | 1 | February 28, 2003 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | December 17, 1993 | 0 | 0 | 0 | api.fda.gov |
| Bear Medic Corporation | Daigomachi, Kuji-gun Ibaraki, Japan | Manufacturer | 1 | October 14, 2004 | 0 | 0 | 0 | api.fda.gov |
| Demetech Corp. | Miami Lakes, FL, United States | Manufacturer | 1 | June 18, 2003 | 0 | 0 | 0 | api.fda.gov |
| Healthium Medtech Limited | BANGALORE Karnataka, India | Manufacturer | 1 | June 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| Healthium Medtech Limited | SRI CITY Andhra Pradesh, India | Manufacturer | 1 | June 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| Internacional Farmaceutica, S.A. De C.V. | Mexico City, Mexico | Manufacturer | 1 | February 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| Internacional Farmaceutica, S.A. De C.V. | LERMA Mexico, Mexico | Manufacturer | 1 | February 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| Keisei Medical Industrial Co., Ltd. | BUNKYO-KU Tokyo, Japan | Manufacturer | 1 | March 30, 2000 | 0 | 0 | 0 | api.fda.gov |
| Kono Seisakusho | Ichikawa Chiba, Japan | Complaint file establishment, Manufacturer | 1 | May 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Mani, Inc. (head Office) | UTSUNOMIYA Tochigi, Japan | Manufacturer | 1 | May 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Nashville Surgical Instruments | Springfield, TN, United States | Specification developer | 1 | July 15, 2008 | 0 | 0 | 0 | api.fda.gov |
| Orion Sutures (india) Private Limited | BENGALURU Karnataka, India | Manufacturer | 1 | July 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Peters Surgical | BOULOGNE-BILLANCOURT Hauts-de-Seine, France | Exporter to the US, Specification developer | 1 | August 3, 1992 | 0 | 0 | 0 | api.fda.gov |
| Shandong Haidike Medical Products Co., Ltd | Heze Shandong, China | Manufacturer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Smeng Co.,ltd. | Busan, South Korea | Manufacturer | 1 | March 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Specification developer | 1 | October 28, 2015 | 0 | 0 | 0 | api.fda.gov |
| Surgical Specialties Mexico S DE RL DE CV | Tijuana Baja California, Mexico | Manufacturer | 1 | October 25, 1990 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | July 7, 1998 | 0 | 1 | 0 | api.fda.gov |
| Unilene, Sac | Lima Lima(Region), Peru | Manufacturer | 1 | May 28, 2013 | 0 | 0 | 0 | api.fda.gov |
| United Medical Industries Co. Ltd. | RIYADH Ar Riyad, Saudi Arabia | Manufacturer | 1 | December 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Visionary Medical Supplies, Inc. | Madison, WI, United States | Manufacturer | 1 | February 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | CIUDAD JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, LLC. | San Lorenzo, PR, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon LLC | Manati, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foosin Medical Supplies Inc.ltd | WEIHAI Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Golnit Ltd | Kiev Kyyiv, Misto, Ukraine | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kollsut International Inc | North Miami Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medisut, S.A. | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meril Endo Surgery Pvt. Ltd. | Vapi Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd Pho Yen 2 Factory | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medizin Produkte Neustadt GmbH (MPN) | Neustadt in Holstein Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peters Surgical International Co., Ltd | Bangkok Krung Thep Maha Nakhon, Thailand | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Fibers OEM LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RESORBA Medical GmbH | NUERNBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resorba, s.r.o | Domazlice, Czechia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sharp Fluidics, Inc. | El Granada, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirius Engineering LLC | San Carlos, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.