Data / Medical devices / Staple, Implantable / United States
FDA-registered makers of Staple, Implantable in the United States: 49 establishments
49 establishments in the United States are registered with the FDA to make Staple, Implantable (product code GDW). 21 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
- Staple, Implantable
- Product code
- GDW
- Country
- United States
Makers of Staple, Implantable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Covidien | North Haven, CT, United States | Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 46 | April 10, 2026 | 0 | 23 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Manufacturer for export, Specification developer | 26 | May 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 23 | May 11, 2026 | 0 | 19 | 4 | api.fda.gov |
| Covidien | Ponce, PR, United States | Contract manufacturer, Manufacturer | 21 | April 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 8 | February 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 5 | July 16, 2019 | 0 | 2 | 0 | api.fda.gov |
| Lexington Medical, Inc. | Bedford, MA, United States | Complaint file establishment, Manufacturer | 5 | April 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Specification developer | 2 | June 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 2 | February 5, 2013 | 0 | 1 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Specification developer | 2 | February 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 2 | February 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Anika Therapeutics, Inc. | Bedford, MA, United States | Specification developer | 1 | May 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bolder Surgical, LLC | Louisville, CO, United States | Specification developer | 1 | February 11, 2014 | 0 | 2 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 1 | March 16, 2012 | 0 | 0 | 0 | api.fda.gov |
| Opus KSD, Inc. | East Pembroke, MA, United States | Manufacturer | 1 | April 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 1 | July 12, 2013 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 1 | July 12, 2013 | 0 | 0 | 0 | api.fda.gov |
| Surgin Surgical Instrumentation, Inc. | Scottsdale, AZ, United States | Specification developer | 1 | February 23, 1989 | 0 | 0 | 0 | api.fda.gov |
| Tools For Surgery, LLC | Stony Brook, NY, United States | Manufacturer | 1 | March 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer | 1 | April 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Inc. | Cincinnati, OH, United States | Specification developer | 1 | April 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atalys | Asheboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carbon Medical Technologies, Inc. | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Plastic Components, Inc. | Osceola, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer for export, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Santa Clara, CA, United States | Complaint file establishment, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Grand Prairie, TX, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacey Manufacturing Company LLC | Bridgeport, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mass Precision, Inc. | Fremont, CA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oberg Medical Products Company | Sarver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samax Precision Inc. | Sunnyvale, CA, United States | Contract 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 | |
| Supreme Screw Products | Plainview, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tessy Plastics Corp. | Skaneateles, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Usgi Medical | San Clemente, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Veridiam, LLC | El Cajon, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, Inc | S Plainfield, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.