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 |
|---|---|---|---|
| Oct 24, 2000 | K001070 | RADIOMED SOURCE Radiomed Corp. | KXK |
| Oct 23, 2000 | K002446 | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D Sun Nuclear Corp. | KXK |
| Sep 19, 2000 | K001366 | PROSTEC 125I BRANCHYTHERAPY SNAPSEED Prostec, LLC | KXK |
| Sep 7, 2000 | K001765 | LOOK COLLAGEN SPACERS, MODEL 1514B Surgical Specialties Corp | KXK |
| Aug 22, 2000 | K000475 | BRACHYSEED Draximage, Inc., CA | KXK |
| Jul 17, 2000 | K994018 | PHARMASEED, MODEL BT-125-3 Syncor Pharmaceuticals, Inc. | KXK |
| Jul 14, 2000 | K994016 | PHARMASEED, MODEL BT-103-3 Syncor Pharmaceuticals, Inc. | KXK |
| Jun 9, 2000 | K993701 | PHARMASEED, MODEL BT-125-2 Syncor International, Inc. | KXK |
| Jun 2, 2000 | K993700 | PHARMASEED, MODEL BT-103-2 Syncor International, Inc. | KXK |
| Mar 31, 2000 | K993552 | ISOSEED PD-103 Bebig Isotopentechnik GmbH, DE | KXK |
| Mar 21, 2000 | K994317 | I-PLANT, MODEL 3500 Implant Sciences Corp. | KXK |
| Mar 16, 2000 | K991881 | 125-IMPLANT SEEDS, MODEL STM1250 Sourcetech Medical, LLC | KXK |
| Mar 14, 2000 | K993280 | PROSTEC 125I BRACHYTHERAPY SEEDS Prostec, LLC | KXK |
| Feb 22, 2000 | K991571 | 10 CURIE IRDIUM 192, CSN00100-192 Alpha-Omega Services, Inc. | KXK |
| Jan 14, 2000 | K992007 | PHARMASEED, MODEL BT-103-1 Syncor Pharmaceuticals, Inc. | KXK |
| Dec 23, 1999 | K992008 | PHARMASEED, MODEL BT-125-1 Syncor Pharmaceuticals, Inc. | KXK |
| Nov 5, 1999 | K991344 | WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS Worldwide Medical Technologies, LLC | KXK |
| Oct 20, 1999 | K991280 | 125 IMPLANT SEEDS, MODEL STM1251 Sourcetech Medical, LLC | KXK |
| Oct 4, 1999 | K992262 | INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM Indigo Medical, Inc. | KXK |
| Sep 21, 1999 | K992963 | I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 International Isotopes, Inc. | KXK |
| Jun 17, 1999 | K991526 | ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 Imagyn Medical Technologies, Inc. | KXK |
| Jun 9, 1999 | K984235 | INTERSOURCE 125, MODEL 1251L International Brachytherapy, Inc. | KXK |
| May 20, 1999 | K990193 | IODINE BRACHYTHERAPY SEEDS, MODEL 3000 Implant Sciences Corp. | KXK |
| May 13, 1999 | K982226 | UROMED BRACHYTHERAPHY IODINE-125 SOURCES Uromed Corp. | KXK |
| Apr 16, 1999 | K984446 | `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH Urocor, Inc. | KXK |
| Dec 10, 1998 | K973328 | INTERSOURCE International Brachytherapy S.A., BE | KXK |
| Oct 28, 1997 | K972271 | NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A Ml Strategies, Inc. | KXK |
| Feb 10, 1997 | K964647 | NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE North American Scientific, Inc. | KXK |
| Oct 18, 1995 | K945983 | BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS Bebig Trade, Inc. | KXK |
| Mar 17, 1994 | K936086 | STERILE VIDEO CAMERA COVER AND DRAPE Micromedical Devices, Inc. | KXK |
| Mar 16, 1994 | K931393 | BEBIG PLAQUES RUM101-RUM114 Bebig, Inc. | KXK |
| Dec 13, 1993 | K923697 | RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U Radionics, Inc. | KXK |
| Jul 27, 1993 | K932242 | RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 Best Industries | KXK |
| Jun 4, 1993 | K930570 | RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES Best Industries | KXK |
| Jun 4, 1993 | K924261 | RADIOACTIVE CESIUM-131 SEEDS/SOURCES Best Industries | KXK |
| Dec 30, 1992 | K920880 | BRAINSCAN BRACHYTHERAPY MODULE Brainlab, DE | KXK |
| Sep 21, 1992 | K923130 | IR-192 IMPLANT -- MODIFICATION Omnitron Intl., Inc. | KXK |
| Mar 19, 1992 | K914825 | 1-125 ENDOSEED Endo Technic Corp. | KXK |
| Jan 6, 1992 | K915156 | I-125 SEEDS CODE: 6702 Medi-Physics Inc. Dba Nycomed Amersham Imaging | KXK |
| Nov 22, 1991 | K914281 | I-125 SEEDS, CODE: 6711 Medi-Physics Inc. Dba Nycomed Amersham Imaging | KXK |
| Nov 22, 1991 | K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 Medi-Physics Inc. Dba Nycomed Amersham Imaging | KXK |
| Jun 10, 1991 | K910710 | RADIOACTIVE SEEDS Best Assoc. Corp. | KXK |
| May 8, 1991 | K911775 | OMNICATH IMPLANTED CATHETER AND DEPOT Omnitron Intl., Inc. | KXK |
| Dec 7, 1990 | K902488 | MODIFIED CASS SYSTEM Medical Instrumentation & Diagnostics Corp.(Midco) | KXK |
| Oct 12, 1990 | K903465 | IR-192 IMPLANT Rads S.L., Inc. | KXK |
| Aug 10, 1990 | K902622 | MANAN PROSTATE SEEDING NEEDLE Manan Medical Products, Inc. | KXK |
| Jul 11, 1990 | K896197 | COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT Colab Intl., Inc. | KXK |
| Aug 21, 1985 | K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 Syncor Intl. Corp. | KXK |
| Aug 21, 1985 | K850433 | CESIUM 137 ENDOMETRIAL SOURCE Syncor Intl. Corp. | KXK |
| Mar 26, 1985 | K850434 | CS137 SEALED SOURCES Syncor Intl. Corp. | KXK |
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