Data / Medical devices / Catheter, Embolectomy / United States
FDA-registered makers of Catheter, Embolectomy in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Catheter, Embolectomy (product code DXE). 17 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Embolectomy
- Product code
- DXE
- Country
- United States
Makers of Catheter, Embolectomy in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 9 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 9 | August 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 5 | February 19, 1998 | 0 | 2 | 1 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 5 | February 19, 1998 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 5 | September 7, 2021 | 0 | 7 | 1 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 5 | September 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| Lucas Medical, Inc. | Orange, CA, United States | Manufacturer | 3 | July 1, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cook Vandergrift Inc. | Vandergrift, PA, United States | Complaint file establishment, Manufacturer | 2 | July 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 2 | July 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Manufacturer for export | 2 | July 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | February 25, 1991 | 0 | 5 | 1 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Specification developer | 1 | August 28, 2024 | 0 | 3 | 0 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 1 | September 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Manufacturer | 1 | September 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Vascular | Warren, NJ, United States | Specification developer | 1 | July 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | February 25, 1991 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer | 1 | March 6, 1998 | 0 | 2 | 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.