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
97–120 of 151
Cleared Apr 26, 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283
Theragenics Corp.
Radiology · 86d
Cleared Apr 25, 2001
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K003206
Proxima Therapeutics, Inc.
Radiology · 194d
Cleared Apr 11, 2001
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K010821
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Radiology · 23d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429
Nucletron Corp.
Radiology · 178d
Cleared Oct 24, 2000
RADIOMED SOURCE
K001070
Radiomed Corp.
Radiology · 204d
Cleared Oct 23, 2000
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K002446
Sun Nuclear Corp.
Radiology · 75d
Cleared Sep 19, 2000
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
K001366
Prostec, LLC
Radiology · 172d
Cleared Sep 07, 2000
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765
Surgical Specialties Corp
Radiology · 87d
Cleared Aug 22, 2000
BRACHYSEED
K000475
Draximage, Inc.
Radiology · 189d
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018
Syncor Pharmaceuticals, Inc.
Radiology · 234d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016
Syncor Pharmaceuticals, Inc.
Radiology · 231d
Cleared Jun 09, 2000
PHARMASEED, MODEL BT-125-2
K993701
Syncor International, Inc.
Radiology · 220d
Cleared Jun 02, 2000
PHARMASEED, MODEL BT-103-2
K993700
Syncor International, Inc.
Radiology · 213d
Cleared Mar 31, 2000
ISOSEED PD-103
K993552
Bebig Isotopentechnik GmbH
Radiology · 163d
Cleared Mar 21, 2000
I-PLANT, MODEL 3500
K994317
Implant Sciences Corp.
Radiology · 90d
Cleared Mar 16, 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881
Sourcetech Medical, LLC
Radiology · 288d
Cleared Mar 14, 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280
Prostec, LLC
Radiology · 166d
Cleared Feb 22, 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571
Alpha-Omega Services, Inc.
Radiology · 293d
Cleared Jan 14, 2000
PHARMASEED, MODEL BT-103-1
K992007
Syncor Pharmaceuticals, Inc.
Radiology · 213d
Cleared Dec 23, 1999
PHARMASEED, MODEL BT-125-1
K992008
Syncor Pharmaceuticals, Inc.
Radiology · 191d
Cleared Nov 05, 1999
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
K991344
Worldwide Medical Technologies, LLC
Radiology · 200d
Cleared Oct 20, 1999
125 IMPLANT SEEDS, MODEL STM1251
K991280
Sourcetech Medical, LLC
Radiology · 189d
Cleared Oct 04, 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262
Indigo Medical, Inc.
Radiology · 90d
Cleared Sep 21, 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963
International Isotopes, Inc.
Radiology · 19d