Data / Medical devices / Mesh, Surgical, Absorbable, Staple Line Reinforcement
Mesh, Surgical, Absorbable, Staple Line Reinforcement (OXC): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Mesh, Surgical, Absorbable, Staple Line Reinforcement (product code OXC, Class 2, 21 CFR 878.3300). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on January 9, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OXC
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Japan | 1 |
| Mexico | 1 |
| Germany | 1 |
Makers of Mesh, Surgical, Absorbable, Staple Line Reinforcement
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 |
|---|---|---|---|---|---|---|---|---|
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 3 | January 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 2 | January 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Gunze Limited | Ayabe Kyoto, Japan | Manufacturer | 2 | August 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer | 1 | October 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Inc. | Cincinnati, OH, United States | Specification developer | 1 | October 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | October 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc. | Elkton, MD, United States | Manufacturer | 1 | August 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | North Haven, CT, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Johnson & Johnson MEDICAL GmbH | NORDERSTEDT Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 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.