Data / Medical devices / Probe, Radiofrequency Lesion / United States
FDA-registered makers of Probe, Radiofrequency Lesion in the United States: 29 establishments
29 establishments in the United States are registered with the FDA to make Probe, Radiofrequency Lesion (product code GXI). 16 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Probe, Radiofrequency Lesion
- Product code
- GXI
- Country
- United States
Makers of Probe, Radiofrequency Lesion in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 8 | December 22, 2020 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Neuromodulation Corporation | Valencia, CA, United States | Complaint file establishment, Specification developer | 8 | October 26, 2022 | 0 | 4 | 0 | api.fda.gov |
| Abbott Medical | Plano, TX, United States | Complaint file establishment, Specification developer | 6 | May 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Specification developer | 6 | May 27, 2025 | 0 | 1 | 0 | api.fda.gov |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, United States | Manufacturer | 4 | July 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| Stratus Medical | Magnolia, TX, United States | Complaint file establishment, Specification developer | 3 | February 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | October 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Manufacturer | 2 | October 14, 2008 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Epimed International, Inc. | Johnstown, NY, United States | Manufacturer | 2 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer | 1 | March 17, 1988 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 1 | February 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Neuroone Medical Technologies Corp. | Eden Prairie, MN, United States | Complaint file establishment, Specification developer | 1 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| PMT Corp. | Chanhassen, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | November 12, 1980 | 0 | 0 | 0 | api.fda.gov |
| Spectra Medical Devices, LLC | Wilmington, MA, United States | Manufacturer | 1 | October 9, 2003 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | May 15, 2025 | 0 | 1 | 0 | api.fda.gov |
| Benchmark Electronics, Inc. | Rochester, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geotec, Inc. | Warwick, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qxmedical, LLC | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RBC Development LLC dba RBC Medical Innovations dba Vantage MedTech | Olathe, KS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, United States | Contract manufacturer | 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.