ClearanceBrief
Panels › General, Plastic Surgery › Product code GEH · Class 2

Unit, Cryosurgical, Accessories

Regulation 878.4350

9510(k)s in 12 months (264 all time)
5recalls in 12 months (107 all time)
87recalls that name a 510(k)
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Top companies in GEH

Company510(k)sRecalls
Boston Scientific553
Galil Medical , Ltd.297
CSA Medical, Inc.142
Endocare, Inc.131
Cooper Surgical, Inc.013
AtriCure, Inc.83
C2 Therapeutics81
Cryomedical Sciences, Inc.90
OraSure Technologies, Inc.63
Cryoconcepts LP80
Decided510(k)Device and applicantCode
Jun 25, 2015K141110CRYOCARE CS SURGICAL SYSTEM
Healthtronics
GEH
Jun 17, 2015K150920truFreeze System
CSA Medical, Inc.
GEH
May 4, 2015K151041ERBECRYO 2 Cryosurgical Unit with accessories
Erbe USA, Inc.
GEH
Mar 5, 2015K143564Visual-ICE Cryoablation System, Software Revision 1.3.1
Galil Medical, Inc.
GEH
Jan 15, 2015K143625truFreeze System
CSA Medical, Inc.
GEH
Oct 29, 2014K142441cryoICE croablation probe
AtriCure, Inc.
GEH
Jul 2, 2014K141485ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
Galil Medical , Ltd.
GEH
Jun 19, 2014K133258TRUFREEZE SYSTEM
CSA Medical, Inc.
GEH
Jun 12, 2014K140314WARTIE WART REMOVER
Yonmedical BV
GEH
Mar 31, 2014K140584ICEROD CX CRYOABLATION NEEDLE
Galil Medical , Ltd.
GEH
Jan 24, 2014K140058ATRICURE CRYO MODULE SYSTEM
AtriCure, Inc.
GEH
Aug 22, 2013K131523CRYOBALLOON FOCAL ABLATION SYSTEM
C2 Therapeutics
GEH
Jun 14, 2013K130995NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
Nuance Medical, LLC
GEH
Jun 5, 2013K130599WART FREEZE
Koninklijke Utermohlen NV
GEH
Feb 6, 2013K123865VISUAL-ICE CRYOABLATION SYSTEM
Galil Medical, Inc.
GEH
Aug 28, 2012K121251ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
Galil Medical , Ltd.
GEH
Jun 6, 2012K121507ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
AtriCure, Inc.
GEH
Mar 12, 2012K113860VISUAL-ICE CRYOABLATION SYSTEM
Galil Medical, Inc.
GEH
Feb 7, 2012K113021TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
CSA Medical, Inc.
GEH
Oct 7, 2011K111859ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
Galil Medical, Inc.
GEH
Sep 9, 2011K110754CRYOPEN CRYOSURGICAL SYSTEM, K102214
Cryopen, Inc.
GEH
Aug 3, 2011K112072ATRICURE CRYO MODULE SYSTEM
AtriCure, Inc.
GEH
Jun 23, 2011K101049WART FREEZE
Koninklijke Utermohlen NV, CA
GEH
Jun 21, 2011K110946ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
Galil Medical , Ltd., IL
GEH
May 26, 2011K111042ATRICURE CRYO MODULE
AtriCure, Inc.
GEH
Feb 9, 2011K103310CRYONIZE TM
3jt Enterprises, LLC
GEH
Nov 29, 2010K102360ICESENCE 3
IceCure Medical , Ltd., IL
GEH
Oct 6, 2010K102006CRYOMEGA
Stc Consulting, LLC
GEH
Sep 29, 2010K101825CRYOBALLOON ABLATION SYSTEM
C2 Therapeutics
GEH
Jun 14, 2010K101333CRYOCARE CS SURGICAL SYSTEM
Endocare, Inc.
GEH
Oct 2, 2009K091721CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
New Medical Technologies GmbH
GEH
Aug 10, 2009K090978UC-CARE WARMING SYSTEM
UC-CARE , Ltd.
GEH
Mar 20, 2009K083493MYOSCIENCE CRYO-TOUCH
Myoscience, Inc.
GEH
Mar 2, 2009K082074ATRICURE CRYO1 CRYO-ABLATION PROBE
AtriCure, Inc.
GEH
Feb 7, 2008K073533SANARUS V2 TREATMENT SYSTEM
Sanarus Medical, Inc.
GEH
Dec 10, 2007K072883ICE-SENSE
Arbel Medical , Ltd.
GEH
Dec 7, 2007K072651CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
CSA Medical, Inc.
GEH
Dec 3, 2007K072453CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T
Brymill Corp.
GEH
May 1, 2007K070893CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500
CSA Medical, Inc.
GEH
Mar 20, 2007K070482ISIS
Galil Medical , Ltd.
GEH
Jan 3, 2007K062896V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
Sanarus Medical, Inc.
GEH
Aug 28, 2006K062175CRYOCARE CN2 SYSTEM
Endocare, Inc.
GEH
Jul 18, 2006K061510SANARUS VISICA TREATMENT SYSTEM
Sanarus Medical, Inc.
GEH
Jul 18, 2006K060859COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
OraSure Technologies, Inc.
GEH
May 22, 2006K060928CRYOSHAPE
Etgar Group H.M.Y.A. , Ltd., IL
GEH
Apr 27, 2006K060390SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
Galil Medical , Ltd.
GEH
Apr 21, 2006K060555SPRAYGENIX CRYO ABLATION SYSTEM
Crymed Technologies, Inc.
GEH
Feb 28, 2006K060279CRYOCARE CS SURGICAL SYSTEM
Endocare, Inc.
GEH
Feb 13, 2006K060144SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
Galil Medical , Ltd.
GEH
Dec 14, 2005K052259DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
Schering-Plough Healthcare Products, Inc.
GEH

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