KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

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

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
121–144 of 151
Cleared Jun 17, 1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K991526
Imagyn Medical Technologies, Inc.
Radiology · 45d
Cleared Jun 09, 1999
INTERSOURCE 125, MODEL 1251L
K984235
International Brachytherapy, Inc.
Radiology · 196d
Cleared May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193
Implant Sciences Corp.
Radiology · 119d
Cleared May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226
Uromed Corp.
Radiology · 323d
Cleared Apr 16, 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446
Urocor, Inc.
Radiology · 123d
Cleared Dec 10, 1998
INTERSOURCE
K973328
International Brachytherapy S.A.
Radiology · 462d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271
Ml Strategies, Inc.
Radiology · 132d
Cleared Feb 10, 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647
North American Scientific, Inc.
Radiology · 82d
Cleared Oct 18, 1995
BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
K945983
Bebig Trade, Inc.
Radiology · 314d
Cleared Mar 17, 1994
STERILE VIDEO CAMERA COVER AND DRAPE
K936086
Micromedical Devices, Inc.
Radiology · 86d
Cleared Mar 16, 1994
BEBIG PLAQUES RUM101-RUM114
K931393
Bebig, Inc.
Radiology · 362d
Cleared Dec 13, 1993
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697
Radionics, Inc.
Radiology · 507d
Cleared Jul 27, 1993
RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
K932242
Best Industries
Radiology · 81d
Cleared Jun 04, 1993
RADIOACTIVE CESIUM-131 SEEDS/SOURCES
K924261
Best Industries
Radiology · 284d
Cleared Jun 04, 1993
RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
K930570
Best Industries
Radiology · 120d
Cleared Dec 30, 1992
BRAINSCAN BRACHYTHERAPY MODULE
K920880
Brainlab
Radiology · 308d
Cleared Sep 21, 1992
IR-192 IMPLANT -- MODIFICATION
K923130
Omnitron Intl., Inc.
Radiology · 88d
Cleared Mar 19, 1992
1-125 ENDOSEED
K914825
Endo Technic Corp.
Radiology · 143d
Cleared Jan 06, 1992
I-125 SEEDS CODE: 6702
K915156
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Radiology · 53d
Cleared Nov 22, 1991
I-125 SEEDS IN CARRIER, CODE: 6720
K914268
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Radiology · 60d
Cleared Nov 22, 1991
I-125 SEEDS, CODE: 6711
K914281
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Radiology · 59d
Cleared Jun 10, 1991
RADIOACTIVE SEEDS
K910710
Best Assoc. Corp.
Radiology · 110d
Cleared May 08, 1991
OMNICATH IMPLANTED CATHETER AND DEPOT
K911775
Omnitron Intl., Inc.
Radiology · 37d
Cleared Dec 07, 1990
MODIFIED CASS SYSTEM
K902488
Medical Instrumentation & Diagnostics Corp.(Midco)
Radiology · 191d