Data / Medical devices / Mesh, Surgical, Absorbable, Abdominal Hernia
Mesh, Surgical, Absorbable, Abdominal Hernia (OWT): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Mesh, Surgical, Absorbable, Abdominal Hernia (product code OWT, Class 2, 21 CFR 878.3300). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on October 16, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OWT
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Sweden | 1 |
| France | 1 |
Makers of Mesh, Surgical, Absorbable, Abdominal Hernia
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 |
|---|---|---|---|---|---|---|---|---|
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 5 | September 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Davol Inc. | Woburn, MA, United States | Manufacturer | 1 | October 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| Novus Scientific AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 1 | March 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sofradim Production | TREVOUX Auvergne-Rhone-Alpes, France | Manufacturer | 1 | February 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc. | Elkton, MD, United States | Manufacturer | 1 | July 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 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.