Data / Medical devices / Source, Brachytherapy, Radionuclide / United States
FDA-registered makers of Source, Brachytherapy, Radionuclide in the United States: 20 establishments
20 establishments in the United States are registered with the FDA to make Source, Brachytherapy, Radionuclide (product code KXK). 14 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Source, Brachytherapy, Radionuclide
- Product code
- KXK
- Country
- United States
Makers of Source, Brachytherapy, Radionuclide in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Theragenics Corp. | Buford, GA, United States | Manufacturer | 9 | October 18, 2011 | 0 | 1 | 0 | api.fda.gov |
| Best Medical International, Inc. | Springfield, VA, United States | Manufacturer, Repackager or relabeler | 8 | January 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| Isoaid, L.L.C. | Port Richey, FL, United States | Manufacturer, Manufacturer for export | 6 | July 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bard Brachytherapy, Inc | Carol Stream, IL, United States | Manufacturer | 4 | May 2, 2014 | 0 | 1 | 0 | api.fda.gov |
| GT Medical Technologies, Inc | Tempe, AZ, United States | Complaint file establishment, Specification developer | 4 | November 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| GT Medical Technologies | Richland, WA, United States | Manufacturer | 4 | November 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| GT Medical Technologies | Richland, WA, United States | Manufacturer | 4 | August 28, 2009 | 0 | 0 | 0 | api.fda.gov |
| CivaTech Oncology Inc. | Morrisville, NC, United States | Manufacturer | 3 | September 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| C4 Imaging LLC | Bellaire, TX, United States | Specification developer | 2 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Izi Medical Products LLC | Owings Mills, MD, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | April 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer, Manufacturer | 1 | August 10, 1990 | 0 | 1 | 0 | api.fda.gov |
| Hologic, Inc. | Marlborough, MA, United States | Specification developer | 1 | April 25, 2001 | 0 | 0 | 0 | api.fda.gov |
| LV Liberty Vision | Portsmouth, NH, United States | Manufacturer | 1 | May 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | February 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Alpha-Omega Services, Inc. | Vinton, LA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha-Omega Services, Inc. | Bellflower, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Tool Engineering, Inc. | West Palm Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa-Global Inc. | Burlington, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Standard Imaging, Inc. | Middleton, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.