KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Cp Medical, Worldwide Medical Technologies, LLC and Implant Sciences Corp..

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
49–72 of 151
Cleared May 22, 2007
AOS MARKER SEEDS
K062825
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared Mar 23, 2007
IMPLANT SCIENCES CORP. MODEL HDR 4454
K070468
Implant Sciences Corp.
Radiology · 35d
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
Cleared Jan 26, 2005
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K043596
Theragenics Corp.
Radiology · 28d
Cleared Jan 21, 2005
OPTISTRAND, MODEL 1032S
K043336
Ibt SA
Radiology · 49d
Cleared Jan 06, 2005
IMPLANT SCIENCES CORP, MODEL HDR-4140
K042864
Implant Sciences Corp.
Radiology · 80d
Cleared Dec 09, 2004
BEST RADIOPAQUE STRAND
K043117
Best Medical International, Inc.
Radiology · 29d
Cleared Nov 18, 2004
BEST MODEL # 81-01 SERIES IR-192 SOURCES
K042786
Best Medical International, Inc.
Radiology · 43d
Cleared Jul 22, 2004
OPTISOURCE, MODEL 1032P
K040766
International Brachytherapy S.A.
Radiology · 119d
Cleared Jul 16, 2004
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
K041702
Ibt SA
Radiology · 24d
Cleared Jul 02, 2004
SOURCELINK
K041576
C.R. Bard, Inc.
Radiology · 21d
Cleared Apr 08, 2004
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
K033770
Isoaid, LLC
Radiology · 127d
Cleared Apr 08, 2004
BRACHYTHERAPY STRAND DEVICE
K040339
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 57d
Cleared Jan 30, 2004
CP SLEEVE AND RIVER SLEEVE
K034062
Cp Medical
Radiology · 30d
Cleared Dec 30, 2003
BEBIG ISOSEED I-125
K033781
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 26d
Cleared Jul 02, 2003
READI-STRAND, MODEL PSSTRAND
K023179
Worldwide Medical Technologies, LLC
Radiology · 281d