Data / Medical devices / Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (OXH): 14 FDA-registered makers in 3 countries
14 establishments in 3 countries are registered with the FDA to make Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (product code OXH, Class 2, 21 CFR 878.3300). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 15, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OXH
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Iceland | 2 |
| Germany | 1 |
Makers of Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
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 |
|---|---|---|---|---|---|---|---|---|
| Integra LifeSciences Braintree Inc. | Braintree, MA, United States | Manufacturer | 1 | June 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kerecis Ehf | Isafjordur Vestfiroir, Iceland | Complaint file establishment, Manufacturer | 1 | May 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kerecis Ehf | Isafjordur Vestfiroir, Iceland | Complaint file establishment, Manufacturer | 1 | May 2, 2021 | 0 | 0 | 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 | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Roswell, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Biotech, Inc. | West Lafayette, IN, United States | 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 | |
| DSM Biomedical, Inc. | Exton, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecell Corp | Branchburg, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecell Corp. | Branchburg, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tutogen Medical GmBH | Neunkirchen am Brand Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 15, 2025. 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.