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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2007 | K062214 | BRACHYSCIENCES STRANDPORT Worldwide Medical Technologies, LLC | KXK |
| Nov 30, 2006 | K063177 | RAPID STRAND RX Oncura, Inc. | KXK |
| Nov 9, 2006 | K062384 | CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE Isoray, Inc. | KXK |
| Aug 4, 2006 | K061638 | BEST STRAND AND BEST SPACER Best Medical International, Inc. | KXK |
| Apr 21, 2006 | K060679 | SURTRAK IMPLANTATION KIT North American Scientific, Inc. | KXK |
| Apr 19, 2006 | K060636 | PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE C.R. Bard, Inc. | KXK |
| Feb 28, 2006 | K053595 | CURAY CUSTOM SEED ARRAY Biolucent, Inc. | KXK |
| Sep 7, 2005 | K052024 | NSTRAND IMPLANTATION KIT North American Scientific, Inc. | KXK |
| Feb 2, 2005 | K043246 | BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS C.R. Bard, Inc. | KXK |
| Jan 26, 2005 | K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 Theragenics Corp. | KXK |
| Jan 21, 2005 | K043336 | OPTISTRAND, MODEL 1032S Ibt SA | KXK |
| Jan 6, 2005 | K042864 | IMPLANT SCIENCES CORP, MODEL HDR-4140 Implant Sciences Corp. | KXK |
| Dec 9, 2004 | K043117 | BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER Best Medical International, Inc. | KXK |
| Nov 18, 2004 | K042786 | BEST MODEL # 81-01 SERIES IR-192 SOURCES Best Medical International, Inc. | KXK |
| Jul 22, 2004 | K040766 | OPTISOURCE, MODEL 1032P International Brachytherapy S.A. | KXK |
| Jul 16, 2004 | K041702 | EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) Ibt SA | KXK |
| Jul 2, 2004 | K041576 | SOURCELINK C.R. Bard, Inc. | KXK |
| Apr 8, 2004 | K040339 | BRACHYTHERAPY STRAND DEVICE Bebig Isotopen-Und Medizintechnik GmbH, DE | KXK |
| Apr 8, 2004 | K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A Isoaid, LLC | KXK |
| Jan 30, 2004 | K034062 | CP SLEEVE AND RIVER SLEEVE Cp Medical | KXK |
| Dec 30, 2003 | K033781 | BEBIG ISOSEED I-125 Bebig Isotopen-Und Medizintechnik GmbH, DE | KXK |
| Jul 2, 2003 | K023179 | READI-STRAND, MODEL PSSTRAND Worldwide Medical Technologies, LLC | KXK |
| Jun 10, 2003 | K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 Med-Tec,Inc. | KXK |
| Jun 9, 2003 | K022705 | READI-STRAND, MODEL PSSTRAND Worldwide Medical Technologies, LLC | KXK |
| May 21, 2003 | K030534 | VARISEED 7.1 Varian Medical Systems | KXK |
| May 6, 2003 | K022389 | READI-LOAD SYSTEM, MODEL PSS 1820RL Worldwide Medical Technologies, LLC | KXK |
| Apr 10, 2003 | K030594 | I-125 RAPID STRAND, MODEL 7000 Amersham Health | KXK |
| Apr 7, 2003 | K023073 | SEED LINK Implant Sciences Corp. | KXK |
| Mar 28, 2003 | K030162 | LAWRENCE CSERION, MODEL CS-1 Isoray, Inc. | KXK |
| Mar 28, 2003 | K023210 | SEEDLINKS, MODELS 70301, 70302, 70303 Sourcetech Medical, LLC | KXK |
| Mar 17, 2003 | K024183 | ALTON PT STEPPER Alton Design, LLC | KXK |
| Mar 12, 2003 | K030745 | GAMMAMED 212 AND 232 SOURCE ASSEMBLY Varian Medical Systems | KXK |
| Mar 11, 2003 | K010705 | OPTIDOS Ptw-New York Corp. | KXK |
| Dec 17, 2002 | K020683 | ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 Ati Medical, Inc. | KXK |
| Dec 4, 2002 | K023242 | I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE Implant Sciences Corp. | KXK |
| Jul 29, 2002 | K020337 | READI-STRAND; MODEL PSSTRAND Worldwide Medical Technologies, LLC | KXK |
| Jul 13, 2002 | K021311 | SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL Cp Medical | KXK |
| May 20, 2002 | K021343 | ISOSEEDS I-125 Bebig Isotopen-Und Medizintechnik GmbH, DE | KXK |
| Feb 22, 2002 | K013975 | CP-SLEEVE Cp Medical | KXK |
| Jan 24, 2002 | K013964 | MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS Cp Medical | KXK |
| Dec 5, 2001 | K013660 | GENETRA Radiomed Corporation | KXK |
| Sep 4, 2001 | K010621 | ACCU-SPACE ABSORBABLE SEEDING SPACERS Cp Medical | KXK |
| Aug 31, 2001 | K011427 | MBI PD-103 SL; MBI PD-103 SH Mills Biopharmaceuticals, Inc. | KXK |
| Jul 12, 2001 | K011155 | INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S Ibt, Inc. | KXK |
| Jul 10, 2001 | K011205 | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 Isoaid | KXK |
| Jun 25, 2001 | K011119 | BRACHYSEED PD-103 MODELS #PD1 Draximage, Inc., CA | KXK |
| Apr 26, 2001 | K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 Theragenics Corp. | KXK |
| Apr 25, 2001 | K003206 | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 Proxima Therapeutics, Inc. | KXK |
| Apr 11, 2001 | K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 Medi-Physics Inc. Dba Nycomed Amersham Imaging | KXK |
| Feb 2, 2001 | K002429 | SELECT SEED I-125 Nucletron Corp. | KXK |
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