Data / Medical devices / Stapler, Surgical / United States
FDA-registered makers of Stapler, Surgical in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Stapler, Surgical (product code GAG). 7 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Stapler, Surgical
- Product code
- GAG
- Country
- United States
Makers of Stapler, Surgical 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 | 4 | July 1, 2026 | 0 | 1 | 0 | api.fda.gov |
| Covidien | Ponce, PR, United States | Contract manufacturer, Manufacturer | 3 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 2 | July 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 1 | April 8, 2022 | 0 | 2 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 1 | March 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 1 | March 10, 2025 | 0 | 1 | 0 | api.fda.gov |
| Lexington Medical, Inc. | Bedford, MA, United States | Complaint file establishment, Manufacturer | 1 | May 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bolder Surgical, LLC | Louisville, CO, United States | Specification developer | 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 | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, 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.