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GEH

263 FDA 510(k) clearances · Product code

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RecordFirmDate
truFreeze System (K150920)CSA Medical, Inc.2015-06-17
ERBECRYO 2 Cryosurgical Unit with accessories (K151041)Erbe USA, Inc.2015-05-04
Visual-ICE Cryoablation System, Software Revision 1.3.1 (K143564)Galil Medical, Inc.2015-03-05
truFreeze System (K143625)CSA Medical, Inc.2015-01-15
cryoICE croablation probe (K142441)AtriCure, Inc.2014-10-29
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE (K141485)Galil Medical , Ltd.2014-07-02
TRUFREEZE SYSTEM (K133258)CSA Medical, Inc.2014-06-19
WARTIE WART REMOVER (K140314)Yonmedical BV2014-06-12
ICEROD CX CRYOABLATION NEEDLE (K140584)Galil Medical , Ltd.2014-03-31
ATRICURE CRYO MODULE SYSTEM (K140058)AtriCure, Inc.2014-01-24
CRYOBALLOON FOCAL ABLATION SYSTEM (K131523)C2 Therapeutics2013-08-22
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY (K130995)Nuance Medical, LLC2013-06-14
WART FREEZE (K130599)Koninklijke Utermohlen NV2013-06-05
VISUAL-ICE CRYOABLATION SYSTEM (K123865)Galil Medical, Inc.2013-02-06
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK (K121251)Galil Medical , Ltd.2012-08-28
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) (K121507)AtriCure, Inc.2012-06-06
VISUAL-ICE CRYOABLATION SYSTEM (K113860)Galil Medical, Inc.2012-03-12
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT (K113021)CSA Medical, Inc.2012-02-07
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK (K111859)Galil Medical, Inc.2011-10-07
CRYOPEN CRYOSURGICAL SYSTEM, K102214 (K110754)Cryopen, Inc.2011-09-09
ATRICURE CRYO MODULE SYSTEM (K112072)AtriCure, Inc.2011-08-03
WART FREEZE (K101049)Koninklijke Utermohlen NV2011-06-23
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE (K110946)Galil Medical , Ltd.2011-06-21
ATRICURE CRYO MODULE (K111042)AtriCure, Inc.2011-05-26
CRYONIZE TM (K103310)3jt Enterprises, LLC2011-02-09
ICESENCE 3 (K102360)IceCure Medical , Ltd.2010-11-29
CRYOMEGA (K102006)Stc Consulting, LLC2010-10-06
CRYOBALLOON ABLATION SYSTEM (K101825)C2 Therapeutics2010-09-29
CRYOCARE CS SURGICAL SYSTEM (K101333)Endocare, Inc.2010-06-14
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 (K091721)New Medical Technologies GmbH2009-10-02
UC-CARE WARMING SYSTEM (K090978)UC-CARE , Ltd.2009-08-10
MYOSCIENCE CRYO-TOUCH (K083493)Myoscience, Inc.2009-03-20
ATRICURE CRYO1 CRYO-ABLATION PROBE (K082074)AtriCure, Inc.2009-03-02
SANARUS V2 TREATMENT SYSTEM (K073533)Sanarus Medical, Inc.2008-02-07
ICE-SENSE (K072883)Arbel Medical , Ltd.2007-12-10
CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM (K072651)CSA Medical, Inc.2007-12-07
CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T (K072453)Brymill Corp.2007-12-03
CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 (K070893)CSA Medical, Inc.2007-05-01
ISIS (K070482)Galil Medical , Ltd.2007-03-20
V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 (K062896)Sanarus Medical, Inc.2007-01-03
CRYOCARE CN2 SYSTEM (K062175)Endocare, Inc.2006-08-28
SANARUS VISICA TREATMENT SYSTEM (K061510)Sanarus Medical, Inc.2006-07-18
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM (K060859)OraSure Technologies, Inc.2006-07-18
CRYOSHAPE (K060928)Etgar Group H.M.Y.A. , Ltd.2006-05-22
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA (K060390)Galil Medical , Ltd.2006-04-27
SPRAYGENIX CRYO ABLATION SYSTEM (K060555)Crymed Technologies, Inc.2006-04-21
CRYOCARE CS SURGICAL SYSTEM (K060279)Endocare, Inc.2006-02-28
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS (K060144)Galil Medical , Ltd.2006-02-13
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 (K052259)Schering-Plough Healthcare Products, Inc.2005-12-14
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA (K052530)Galil Medical , Ltd.2005-11-18
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 (K052861)Sanarus Medical, Inc.2005-11-15
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES (K051509)Erbe USA, Inc.2005-07-27
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) (K051052)Galil Medical , Ltd.2005-05-06
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (K050347)Endocare, Inc.2005-02-25
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) (K042667)Galil Medical , Ltd.2004-10-14
POLAR WAND (K041783)Chek-Med Systems2004-09-28
CRYMED CRYO-ABLATOR (K040809)Crymed Technologies, Inc.2004-05-21
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) (K032271)Wartner USA B.V.2003-09-10
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 (K031697)Schering-Plough Healthcare Products, Inc.2003-08-29
CRYOCARE CS SURGICAL SYSTEM (K032333)Endocare, Inc.2003-08-12
WARTNER PRO (K030838)Wartner Medical Products2003-06-27
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM (K031117)Galil Medical , Ltd.2003-05-23
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE (K030303)Cryocath Technologies, Inc.2003-04-29
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (K023487)OraSure Technologies, Inc.2003-03-20
CRYOPROBE (K024009)H&O Equipments, Nv/Sa2003-03-20
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (K023757)Endocare, Inc.2002-12-05
SANARUS VISICA TREATMENT SYSTEM (K022314)Sanarus Medical, Inc.2002-10-15
POLAR WAND (K021387)Chek-Med Systems2002-07-31
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 (K021261)Galil Medical , Ltd.2002-07-03
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM (K021211)Sanarus Medical, Inc.2002-06-26
CRYOPEN AND ACCESSORIES (K012214)Cimex Biotech, LLC2002-04-26
SANARUS VISICA TREATMENT SYSTEM (K020605)Sanarus Medical, Inc.2002-03-08
MODIFICATION TO WARTNER WART REMOVAL SYSTEM (K011708)Wartner Medical Products2002-02-20
SEEDNET, MODEL FP6T5, FP5T5, FP5T3 (K011950)Galil Medical , Ltd.2002-01-29
CRYOCARE SURGICAL SYSTEM (K011074)Endocare, Inc.2002-01-25
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 (K012497)Galil Medical , Ltd.2001-10-30
CRYOCARE SURGICAL SYSTEM (K003811)Endocare, Inc.2001-10-11
CRYOPLAN SYSTEM (K011073)Cryomedical Sciences, Inc.2001-08-22
SEEDNET, MODELS FP6T5, FP5T5, FP5T3 (K010991)Galil Medical , Ltd.2001-05-03
WARTNER WART REMOVAL SYSTEM (K002714)Wartner Medical Products2000-11-28
SURGICAL SYSTEM WITH CRYOGUIDE (K002615)Endocare, Inc.2000-11-13
SEEDNET, MODEL EP6T5, EP5E5 (K003065)Galil Medical , Ltd.2000-10-31
CRYO-HIT (K993965)Galil Medical , Ltd.2000-02-18
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE (K991792)Influence, Inc.1999-08-12
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 (K991517)Galil Medical , Ltd.1999-07-27
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E (K991272)Galil Medical , Ltd.1999-07-12
CRYO-MONO CRYOGRNIC SYSTEM (K991122)Influence, Inc.1999-07-01
HISTOFREEZER DEVICE (K990877)OraSure Technologies, Inc.1999-06-14
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM (K982506)Cryosurgery, Inc.1999-01-27
CRYOPRO MAXI AND CRYOPRO MINI (K982280)Cortex Technology Aps1998-11-25
HISTOFREEZER DEVICE (K982358)OraSure Technologies, Inc.1998-10-02
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 (K982055)Cryomedical Sciences, Inc.1998-09-08
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 (K980668)Cryomedical Sciences, Inc.1998-07-17
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 (K980670)Cryomedical Sciences, Inc.1998-07-17
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS (K980739)OraSure Technologies, Inc.1998-05-26
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM (K980110)Endocare, Inc.1998-04-10
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM (K973686)Endocare, Inc.1997-12-22
HISTOFREEZER VERRUCA PLANA (K971392)OraSure Technologies, Inc.1997-10-21
CRYOGEN CRYOSURGICAL SYSTEM (K972662)Cryogen, Inc.1997-10-01
CMS CRYOLITE (K970995)Cryomedical Sciences, Inc.1997-07-07
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