Source, Brachytherapy, Radionuclide
Regulation 892.5730
1510(k)s in 12 months (151 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in KXK
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 5 | 1 |
| Cp Medical | 6 | 0 |
| Implant Sciences Corp. | 6 | 0 |
| Isoaid | 6 | 0 |
| Worldwide Medical Technologies, LLC | 6 | 0 |
| Isoray Medical, Inc. | 5 | 0 |
| Theragenics Corp. | 4 | 1 |
| Medi-Physics Inc. Dba Nycomed Amersham Imaging | 4 | 0 |
| Source Production and Equipment Co., Inc. | 4 | 0 |
| Syncor Pharmaceuticals, Inc. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2018 | Bard Brachytherapy, Inc. BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The Terminated |
KXK | K093663 |
| Dec 9, 2016 | C.R. Bard, Inc. I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges
Indicated for permanent interstitial treatment of selected localized tumors such as: head an Terminated |
KXK | K043246 |
| Apr 10, 2012 | Varian Medical Systems, Inc. VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy pr Terminated |
KXK | K030534 |
| Nov 22, 2011 | Medi-Physics Inc. dba GE Healthcare Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration withi Terminated |
KXK | K063177 |
| Mar 3, 2008 | Source Production & Equipment Inc M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA.
Brachytherapy source. Terminated |
KXK | K052947 |
| Jul 7, 2005 | Theragenics Corporation PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch Terminated |
KXK | None listed |
| Jun 22, 2005 | Manan Medical Products, Inc. Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, Terminated |
KXK | K902622 |
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