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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Theragenics Corp.Buford, GA, United StatesManufacturer9October 18, 2011010api.fda.gov
Best Medical International, Inc.Springfield, VA, United StatesManufacturer, Repackager or relabeler8January 9, 2013000api.fda.gov
Isoaid, L.L.C.Port Richey, FL, United StatesManufacturer, Manufacturer for export6July 15, 2025000api.fda.gov
Bard Brachytherapy, IncCarol Stream, IL, United StatesManufacturer4May 2, 2014010api.fda.gov
GT Medical Technologies, IncTempe, AZ, United StatesComplaint file establishment, Specification developer4November 9, 2022000api.fda.gov
GT Medical TechnologiesRichland, WA, United StatesManufacturer4November 9, 2022000api.fda.gov
GT Medical TechnologiesRichland, WA, United StatesManufacturer4August 28, 2009000api.fda.gov
CivaTech Oncology Inc.Morrisville, NC, United StatesManufacturer3September 20, 2019000api.fda.gov
C4 Imaging LLCBellaire, TX, United StatesSpecification developer2August 25, 2017000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2April 19, 2012000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1August 10, 1990010api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesSpecification developer1April 25, 2001000api.fda.gov
LV Liberty VisionPortsmouth, NH, United StatesManufacturer1May 29, 2020000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Contract manufacturer, Manufacturer1February 25, 2011000api.fda.gov
Alpha-Omega Services, Inc.Vinton, LA, United StatesContract manufacturer0000api.fda.gov
Alpha-Omega Services, Inc.Bellflower, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Micro Tool Engineering, Inc.West Palm Beach, FL, United StatesContract manufacturer0000api.fda.gov
Qsa-Global Inc.Burlington, MA, United StatesContract manufacturer0000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer0000api.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.