Data / Medical devices / Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene / United States
FDA-registered makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene in the United States: 23 establishments
23 establishments in the United States are registered with the FDA to make Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ). 15 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Product code
- DXZ
- Country
- United States
Makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Elutia Inc. | Gaithersburg, MD, United States | Complaint file establishment, Specification developer | 5 | February 4, 2016 | 0 | 0 | 0 | api.fda.gov |
| Artivion, Inc. | Kennesaw, GA, United States | Complaint file establishment, Manufacturer | 3 | March 9, 2017 | 0 | 8 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc. | Phoenix, AZ, United States | Manufacturer | 3 | September 20, 2001 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Manufacturer, Specification developer | 2 | December 20, 1991 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer | 2 | October 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 2 | November 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer, Specification developer | 2 | November 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 2 | October 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 2 | October 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 1 | August 12, 1981 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC. | San Lorenzo, PR, United States | Manufacturer | 1 | November 7, 2000 | 0 | 0 | 0 | api.fda.gov |
| Lifenet Health | Virginia Beach, VA, United States | Manufacturer | 1 | October 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| LifeNet Health | Virginia Bch, VA, United States | Manufacturer | 1 | October 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| LifeNet Health Northwest | Renton, WA, United States | Manufacturer | 1 | October 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) | Saint Paul, MN, United States | Manufacturer | 1 | November 12, 1998 | 0 | 3 | 1 | api.fda.gov |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | San Angelo, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Fibers OEM LLC | Mansfield, MA, United States | Contract 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 | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 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.