Source, Brachytherapy, Radionuclide

FDA product code KXK · 141 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5730
Review panel: RA
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-12-18 – 2025-12-05

KXK 2000-03-21

I-PLANT, MODEL 3500

Applicant Implant Sciences Corp.

K number K994317

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KXK 2000-03-16

125-IMPLANT SEEDS, MODEL STM1250

Applicant Sourcetech Medical, LLC

K number K991881

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KXK 2000-03-14

PROSTEC 125I BRACHYTHERAPY SEEDS

Applicant Prostec, LLC

K number K993280

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KXK 2000-02-22

10 CURIE IRDIUM 192, CSN00100-192

Applicant Alpha-Omega Services, Inc.

K number K991571

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KXK 2000-01-14

PHARMASEED, MODEL BT-103-1

Applicant Syncor Pharmaceuticals, Inc.

K number K992007

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KXK 1999-12-23

PHARMASEED, MODEL BT-125-1

Applicant Syncor Pharmaceuticals, Inc.

K number K992008

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KXK 1999-11-05

WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS

Applicant Worldwide Medical Technologies, LLC

K number K991344

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KXK 1999-10-20

125 IMPLANT SEEDS, MODEL STM1251

Applicant Sourcetech Medical, LLC

K number K991280

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KXK 1999-10-04

INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM

Applicant Indigo Medical, Inc.

K number K992262

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KXK 1999-09-21

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

Applicant International Isotopes, Inc.

K number K992963

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KXK 1999-06-17

ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501

Applicant Imagyn Medical Technologies, Inc.

K number K991526

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KXK 1999-06-09

INTERSOURCE 125, MODEL 1251L

Applicant International Brachytherapy, Inc.

K number K984235

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KXK 1999-05-20

IODINE BRACHYTHERAPY SEEDS, MODEL 3000

Applicant Implant Sciences Corp.

K number K990193

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KXK 1999-05-13

UROMED BRACHYTHERAPHY IODINE-125 SOURCES

Applicant Uromed Corp.

K number K982226

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KXK 1999-04-16

`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH

Applicant Urocor, Inc.

K number K984446

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KXK 1998-12-10

INTERSOURCE

Applicant International Brachytherapy S.A.

K number K973328

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KXK 1997-10-28

NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A

Applicant Ml Strategies, Inc.

K number K972271

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KXK 1997-02-10

NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE

Applicant North American Scientific, Inc.

K number K964647

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KXK 1995-10-18

BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS

Applicant Bebig Trade, Inc.

K number K945983

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KXK 1994-03-17

STERILE VIDEO CAMERA COVER AND DRAPE

Applicant Micromedical Devices, Inc.

K number K936086

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KXK 1994-03-16

BEBIG PLAQUES RUM101-RUM114

Applicant Bebig, Inc.

K number K931393

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KXK 1993-12-13

RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U

Applicant Radionics, Inc.

K number K923697

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KXK 1993-07-27

RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345

Applicant Best Industries

K number K932242

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KXK 1993-06-04

RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES

Applicant Best Industries

K number K930570

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KXK 1993-06-04

RADIOACTIVE CESIUM-131 SEEDS/SOURCES

Applicant Best Industries

K number K924261

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KXK 1992-12-30

BRAINSCAN BRACHYTHERAPY MODULE

Applicant Brainlab

K number K920880

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KXK 1992-09-21

IR-192 IMPLANT -- MODIFICATION

Applicant Omnitron Intl., Inc.

K number K923130

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KXK 1992-03-19

1-125 ENDOSEED

Applicant Endo Technic Corp.

K number K914825

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KXK 1992-01-06

I-125 SEEDS CODE: 6702

Applicant Medi-Physics Inc. Dba Nycomed Amersham Imaging

K number K915156

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KXK 1991-11-22

I-125 SEEDS, CODE: 6711

Applicant Medi-Physics Inc. Dba Nycomed Amersham Imaging

K number K914281

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KXK 1991-11-22

I-125 SEEDS IN CARRIER, CODE: 6720

Applicant Medi-Physics Inc. Dba Nycomed Amersham Imaging

K number K914268

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KXK 1991-06-10

RADIOACTIVE SEEDS

Applicant Best Assoc. Corp.

K number K910710

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KXK 1991-05-08

OMNICATH IMPLANTED CATHETER AND DEPOT

Applicant Omnitron Intl., Inc.

K number K911775

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KXK 1990-12-07

MODIFIED CASS SYSTEM

Applicant Medical Instrumentation & Diagnostics Corp.(Midco)

K number K902488

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KXK 1990-10-12

IR-192 IMPLANT

Applicant Rads S.L., Inc.

K number K903465

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KXK 1990-08-10

MANAN PROSTATE SEEDING NEEDLE

Applicant Manan Medical Products, Inc.

K number K902622

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KXK 1990-07-11

COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT

Applicant Colab Intl., Inc.

K number K896197

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KXK 1985-08-21

CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41

Applicant Syncor Intl. Corp.

K number K852023

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KXK 1985-08-21

CESIUM 137 ENDOMETRIAL SOURCE

Applicant Syncor Intl. Corp.

K number K850433

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KXK 1985-03-26

CS137 SEALED SOURCES

Applicant Syncor Intl. Corp.

K number K850434

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KXK 1980-12-18

3M I-125 SEEDS IN ABSORBABLE CARRIER

Applicant 3M Company

K number K801748

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