FDA Product Code
FDA Product Code KXK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5730
510(k) Clearances — 151 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001070 | RADIOMED SOURCE | Radiomed Corp. | 2000-10-24 | Traditional | PDF ↗ |
| K002446 | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D | Sun Nuclear Corp. | 2000-10-23 | Traditional | PDF ↗ |
| K001366 | PROSTEC 125I BRANCHYTHERAPY SNAPSEED | Prostec, LLC | 2000-09-19 | Traditional | PDF ↗ |
| K001765 | LOOK COLLAGEN SPACERS, MODEL 1514B | Surgical Specialties Corp | 2000-09-07 | Traditional | PDF ↗ |
| K000475 | BRACHYSEED | Draximage, Inc. | 2000-08-22 | Traditional | PDF ↗ |
| K994018 | PHARMASEED, MODEL BT-125-3 | Syncor Pharmaceuticals, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K994016 | PHARMASEED, MODEL BT-103-3 | Syncor Pharmaceuticals, Inc. | 2000-07-14 | Traditional | PDF ↗ |
| K993701 | PHARMASEED, MODEL BT-125-2 | Syncor International, Inc. | 2000-06-09 | Traditional | PDF ↗ |
| K993700 | PHARMASEED, MODEL BT-103-2 | Syncor International, Inc. | 2000-06-02 | Traditional | PDF ↗ |
| K993552 | ISOSEED PD-103 | Bebig Isotopentechnik GmbH | 2000-03-31 | Traditional | PDF ↗ |
| K994317 | I-PLANT, MODEL 3500 | Implant Sciences Corp. | 2000-03-21 | Traditional | PDF ↗ |
| K991881 | 125-IMPLANT SEEDS, MODEL STM1250 | Sourcetech Medical, LLC | 2000-03-16 | Traditional | PDF ↗ |
| K993280 | PROSTEC 125I BRACHYTHERAPY SEEDS | Prostec, LLC | 2000-03-14 | Traditional | PDF ↗ |
| K991571 | 10 CURIE IRDIUM 192, CSN00100-192 | Alpha-Omega Services, Inc. | 2000-02-22 | Traditional | PDF ↗ |
| K992007 | PHARMASEED, MODEL BT-103-1 | Syncor Pharmaceuticals, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K992008 | PHARMASEED, MODEL BT-125-1 | Syncor Pharmaceuticals, Inc. | 1999-12-23 | Traditional | PDF ↗ |
| K991344 | WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS | Worldwide Medical Technologies, LLC | 1999-11-05 | Traditional | PDF ↗ |
| K991280 | 125 IMPLANT SEEDS, MODEL STM1251 | Sourcetech Medical, LLC | 1999-10-20 | Traditional | PDF ↗ |
| K992262 | INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM | Indigo Medical, Inc. | 1999-10-04 | Traditional | PDF ↗ |
| K992963 | I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 | International Isotopes, Inc. | 1999-09-21 | Special | PDF ↗ |
| K991526 | ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 | Imagyn Medical Technologies, Inc. | 1999-06-17 | Special | PDF ↗ |
| K984235 | INTERSOURCE 125, MODEL 1251L | International Brachytherapy, Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K990193 | IODINE BRACHYTHERAPY SEEDS, MODEL 3000 | Implant Sciences Corp. | 1999-05-20 | Traditional | PDF ↗ |
| K982226 | UROMED BRACHYTHERAPHY IODINE-125 SOURCES | Uromed Corp. | 1999-05-13 | Traditional | PDF ↗ |
| K984446 | `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH | Urocor, Inc. | 1999-04-16 | Traditional | PDF ↗ |
| K973328 | INTERSOURCE | International Brachytherapy S.A. | 1998-12-10 | Traditional | PDF ↗ |
| K972271 | NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A | Ml Strategies, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K964647 | NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE | North American Scientific, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K945983 | BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS | Bebig Trade, Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K936086 | STERILE VIDEO CAMERA COVER AND DRAPE | Micromedical Devices, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K931393 | BEBIG PLAQUES RUM101-RUM114 | Bebig, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K923697 | RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U | Radionics, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K932242 | RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 | Best Industries | 1993-07-27 | Traditional | PDF ↗ |
| K924261 | RADIOACTIVE CESIUM-131 SEEDS/SOURCES | Best Industries | 1993-06-04 | Traditional | PDF ↗ |
| K930570 | RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES | Best Industries | 1993-06-04 | Traditional | PDF ↗ |
| K920880 | BRAINSCAN BRACHYTHERAPY MODULE | Brainlab | 1992-12-30 | Traditional | PDF ↗ |
| K923130 | IR-192 IMPLANT -- MODIFICATION | Omnitron Intl., Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K914825 | 1-125 ENDOSEED | Endo Technic Corp. | 1992-03-19 | Traditional | PDF ↗ |
| K915156 | I-125 SEEDS CODE: 6702 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1992-01-06 | Traditional | PDF ↗ |
| K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991-11-22 | Traditional | PDF ↗ |
| K914281 | I-125 SEEDS, CODE: 6711 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991-11-22 | Traditional | PDF ↗ |
| K910710 | RADIOACTIVE SEEDS | Best Assoc. Corp. | 1991-06-10 | Traditional | PDF ↗ |
| K911775 | OMNICATH IMPLANTED CATHETER AND DEPOT | Omnitron Intl., Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K902488 | MODIFIED CASS SYSTEM | Medical Instrumentation & Diagnostics Corp.(Midco) | 1990-12-07 | Traditional | PDF ↗ |
| K903465 | IR-192 IMPLANT | Rads S.L., Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K902622 | MANAN PROSTATE SEEDING NEEDLE | Manan Medical Products, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K896197 | COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT | Colab Intl., Inc. | 1990-07-11 | Traditional | PDF ↗ |
| K850433 | CESIUM 137 ENDOMETRIAL SOURCE | Syncor Intl. Corp. | 1985-08-21 | Traditional | PDF ↗ |
| K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 | Syncor Intl. Corp. | 1985-08-21 | Traditional | PDF ↗ |
| K850434 | CS137 SEALED SOURCES | Syncor Intl. Corp. | 1985-03-26 | Traditional | PDF ↗ |
| K801748 | 3M I-125 SEEDS IN ABSORBABLE CARRIER | 3M Company | 1980-12-18 | Traditional | PDF ↗ |
Product code KXK · Class II · Radiology. Data: openFDA.