Home › Device types › KXK
Source, Brachytherapy, Radionuclide
FDA product code KXK · Class 2 · Radiology
943
Registered devices
606
Adverse events
7
Recalls
151
510(k) clearances
Devices with this code
Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.Stellar Medical — STELLAR MEDICAL, LLCRu-106 Eye Applicator, type CIB 15 MBq — Eckert & Ziegler BEBIG GmbHAdvantage I-125® — ISOAID, L.L.C.Stellar Medical — STELLAR MEDICAL, LLCAdvantage-Strand® and Advantage-Load® and Advantage Pd-103® — ISOAID, L.L.C.RAPID STRANDTM — MEDI-PHYSICS, INC.Dummy, silver, type CCX — Eckert & Ziegler BEBIG GmbHAdvantage I-125 — ISOAID, L.L.C.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.TheraStrand® with TheraSeed® — THERAGENICS CORPORATIONBrachytherapy Needle — RIVERPOINT MEDICAL, LLCSirius MRI Marker — C4 IMAGING, LLCSirius MRI Marker — C4 IMAGING, LLCTheraStrand® with TheraSeed® — THERAGENICS CORPORATIONTheragenics — THERAGENICS CORPORATIONStellar Medical — STELLAR MEDICAL, LLCBrachySource™ — Bard Brachytherapy, Inc.RAPID STRANDTM — MEDI-PHYSICS, INC.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.TheraSeed® — Bard Brachytherapy, Inc.Best Medical International — BEST MEDICAL INTERNATIONAL, INC.TheraStrand® with TheraSeed® — THERAGENICS CORPORATION
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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