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Data / Medical devices / System, Applicator, Radionuclide, Manual / United States

FDA-registered makers of System, Applicator, Radionuclide, Manual in the United States: 26 establishments

26 establishments in the United States are registered with the FDA to make System, Applicator, Radionuclide, Manual (product code IWJ). 5 have a 510(k) clearance or PMA approval on file and 2 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.

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Device
System, Applicator, Radionuclide, Manual
Product code
IWJ
Country
United States

Makers of System, Applicator, Radionuclide, Manual in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Best Medical International, Inc.Springfield, VA, United StatesManufacturer, Repackager or relabeler5December 30, 1994000api.fda.gov
Mick Radio-Nuclear Instruments, Inc.Mount Vernon, NY, United StatesManufacturer5April 14, 1989000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer1February 24, 1995000api.fda.gov
Best NomosPittsburgh, PA, United StatesComplaint file establishment, Manufacturer1January 2, 1998000api.fda.gov
Theragenics Corp.Buford, GA, United StatesManufacturer1January 23, 1998010api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Bard Brachytherapy, IncCarol Stream, IL, United StatesManufacturer, Specification developer0000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer, Specification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesSpecification developer0000api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer0000api.fda.gov
Isoaid, L.L.C.Port Richey, FL, United StatesManufacturer0000api.fda.gov
Liberty Medical IncSterling, VA, United StatesManufacturer0000api.fda.gov
LV Liberty VisionPortsmouth, NH, United StatesManufacturer0000api.fda.gov
Micro Tool Engineering, Inc.West Palm Beach, FL, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Radiation Products Design, Inc.Albertville, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0020api.fda.gov
Sirtex Medical Inc.Woburn, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer0000api.fda.gov
Sirtex Wilmington LLCWilmington, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Xeridiem Medical DevicesTucson, AZ, United StatesContract manufacturer0000api.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.