KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Cp Medical, C.R. Bard, Inc. and Source Production and Equipment Co., Inc..

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
25–48 of 151
Cleared May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856
C.R. Bard, Inc.
Radiology · 29d
Cleared Jan 02, 2014
SPEC MODEL M15
K132969
Source Production & Equipment Co., Inc.
Radiology · 101d
Cleared Dec 17, 2013
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
K132996
Isoray, Inc.
Radiology · 84d
Cleared Nov 20, 2013
MRI MARKER
K131689
C4 Imaging, LLC
Radiology · 163d
Cleared Jan 09, 2013
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K122704
Best Medical Intl.
Radiology · 127d
Cleared Dec 28, 2012
RAPID STRAND RX
K122764
Medi-Physics, Inc.
Radiology · 109d
Cleared Aug 10, 2012
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K113210
Isoaid, LLC
Radiology · 283d
Cleared Apr 19, 2012
PRE-LOADED GOLD VISICOIL CK MARKER
K120859
Radiomed Corporation
Radiology · 28d
Cleared Oct 18, 2011
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979
Biocompatibles, Inc.
Radiology · 98d
Cleared Aug 05, 2011
GLIASITE RTS
K111931
Isoray Medical, Inc.
Radiology · 28d
Cleared Feb 25, 2011
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449
Riverpoint Medical
Radiology · 94d
Cleared Jan 03, 2011
I-SEED
K103319
Theragenics Corp.
Radiology · 52d
Cleared Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663
C.R. Bard, Inc.
Radiology · 28d
Cleared Jul 18, 2007
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550
Cp Medical
Radiology · 42d
Cleared May 22, 2007
AOS MARKER SEEDS
K062825
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared Mar 01, 2007
BRACHYSCIENCES STRANDPORT
K062214
Worldwide Medical Technologies, LLC
Radiology · 212d
Cleared Nov 30, 2006
RAPID STRAND RX
K063177
Oncura, Inc.
Radiology · 42d
Cleared Nov 09, 2006
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
K062384
Isoray, Inc.
Radiology · 86d
Cleared Aug 04, 2006
BEST STRAND AND BEST SPACER
K061638
Best Medical International, Inc.
Radiology · 53d
Cleared Apr 21, 2006
SURTRAK IMPLANTATION KIT
K060679
North American Scientific, Inc.
Radiology · 37d
Cleared Apr 19, 2006
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636
C.R. Bard, Inc.
Radiology · 40d
Cleared Feb 28, 2006
CURAY CUSTOM SEED ARRAY
K053595
Biolucent, Inc.
Radiology · 67d
Cleared Sep 07, 2005
NSTRAND IMPLANTATION KIT
K052024
North American Scientific, Inc.
Radiology · 43d
Cleared Feb 02, 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246
C.R. Bard, Inc.
Radiology · 71d