Data / Medical devices / Mesh, Surgical, Collagen, Diaphragmatic Hernia
Mesh, Surgical, Collagen, Diaphragmatic Hernia (OWV): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Mesh, Surgical, Collagen, Diaphragmatic Hernia (product code OWV, Class 2, 21 CFR 878.3300). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 20, 2014, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OWV
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Mesh, Surgical, Collagen, Diaphragmatic 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 |
|---|---|---|---|---|---|---|---|---|
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 1 | June 20, 2014 | 0 | 1 | 0 | api.fda.gov |
| Acell, Inc. | Columbia, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 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 |
Updated June 20, 2014. 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.