Home › Device types › KXK
Source, Brachytherapy, Radionuclide
FDA product code KXK · Class 2 · Radiology
946
Registered devices
609
Adverse events
7
Recalls
151
510(k) clearances
Devices with this code
Advantage I-125® — ISOAID, L.L.C.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.TheraStrand® with TheraSeed® — THERAGENICS CORPORATIONBest Medical International — BEST MEDICAL INTERNATIONAL, INC.Advantage I-125® — ISOAID, L.L.C.Gold Fiducial — Izi Medical Products, LLCQuickLink™, SourceLink™ — Bard Brachytherapy, Inc.OncoSeedTM — MEDI-PHYSICS, INC.2PK 0.8X3.0MM GOLD FIDUCIAL LOOSE — Izi Medical Products, LLCBest Medical International — BEST MEDICAL INTERNATIONAL, INC.GOLD MARKER NEEDLE — RIVERPOINT MEDICAL, LLCApplicator Needle — RIVERPOINT MEDICAL, LLCVariStrand RT with I-Seed — THERAGENICS CORPORATIONTheraSeed® — Bard Brachytherapy, Inc.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.TheraSeed®, SourceLink™ — Bard Brachytherapy, Inc.TheraSeed — THERAGENICS CORPORATIONOncoSeedTM — MEDI-PHYSICS, INC.Gold Fiducial — Izi Medical Products, LLCAdvantage-Strand® with Advantage Pd-103® — ISOAID, L.L.C.QuickLink™ — Bard Brachytherapy, Inc.VISICOIL — Izi Medical Products, LLCPL-7 — GT MEDICAL TECHNOLOGIES, INC.Stellar Medical — STELLAR MEDICAL, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-10 | Bard Brachytherapy, Inc. | Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose |
| 2016-12-09 | C.R. Bard, Inc. | Activity and quantity of seeds sent in shipments were incorrect. |
| 2012-01-25 | Varian Medical Systems, Inc. | Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in pati |
| 2011-09-20 | Medi-Physics Inc. dba GE Healthcare | There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy. |
| 2008-03-03 | Source Production & Equipment Inc | Radioactive source broke during use. |
| 2005-05-16 | Theragenics Corporation | The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date. |
| 2005-05-03 | Manan Medical Products, Inc. | The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures. |
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