Unit, Cryosurgical, Accessories
FDA product code GEH · Class II (moderate risk) · 21 CFR 878.4350 · General, Plastic Surgery
264510(k) clearances
0PMA approvals
103recalls
Manufacturers
- Galil Medical , Ltd. 29
- CSA Medical, Inc. 14
- Endocare, Inc. 13
- Cryomedical Sciences, Inc. 9
- C2 Therapeutics, Inc. 8
- Spembly Medical , Ltd. 8
- Cryoconcepts LP 8
- Cryosurgery, Inc. 8
- AtriCure, Inc. 8
- Sanarus Medical, Inc. 7
- OraSure Technologies, Inc. 6
- Recensmedical, Inc. 6
- Wallach Surgical Devices, Inc. 5
- Boston Scientific Corporation 5
- IceCure Medical , Ltd. 4
- Erbe Elektromedizin GmbH 4
- Frigitronics of Connecticut, Inc. 4
- Wartner Medical Products 3
- Candela Laser Corp. 3
- Nuance Medical, LLC 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional | Serpex Medical | 09/02/2026SE |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional | Serpex Medical | 06/30/2026SE |
| K261806 | ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special | Erbe Elektromedizin GmbH | 06/09/2026SE |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | Erbe Elektromedizin GmbH | 04/22/2026SE |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional | Medical Brands Laboratories B.V. | 04/02/2026SE |
| K260377 | XSense Cryoablation System with CryoProbesGEH · Special | IceCure Medical , Ltd. | 02/24/2026SE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional | Medinice S.A. | 02/13/2026SE |
| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
| K253000 | CryoFreeze Wart and Skin Tag RemoverGEH · Special | Cryosurgery, Inc. | 10/16/2025SE |
| K253348 | TargetCool-eGEH · Traditional | Recensmedical, Inc. | 10/15/2025SE |
| K252903 | Verruca-Freeze H PlusGEH · Special | Cryosurgery, Inc. | 10/10/2025SE |
| K251493 | Skin Clinic Freeze Point for Warts and Skin TagsGEH · Special | Cryoconcepts LP | 05/22/2025SE |
| K242932 | Skin Clinic Nitro Clear Wart RemoverGEH · Traditional | Cryoconcepts LP | 04/15/2025SE |
| K243487 | CryoFreeze Wart and Skin Tag RemoverGEH · Traditional | Cryosurgery, Inc. | 03/13/2025SE |
| K243042 | Co-Ablation System with Sterile Co-Ablation ProbeGEH · Traditional | Hygea Medical Technology Co., Ltd. | 01/29/2025SE |
| K242288 | Advanced Cryo Wart RemoverGEH · Traditional | Medical Brands Laboratories B.V. | 01/21/2025SE |
| K243454 | Verruca-Freeze HGEH · Special | Cryosurgery, Inc. | 12/03/2024SE |
| K242803 | Compound W Skin Tag RemoverGEH · Traditional | Medtech Products, Inc. | 11/06/2024SE |
| K242625 | Freeze Point & Private Label VersionsGEH · Traditional | Cryoconcepts LP | 10/25/2024SE |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…GEH · Special | Boston Scientific Corp | 10/18/2024SE |
| K240776 | Celsio Flexible Cryocatheter SystemGEH · Traditional | Endocision Technologies, Inc. | 09/24/2024SE |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH · Traditional | Pentax of America, Inc. | 07/24/2024SE |
| K240892 | XSense Cryoablation System with CryoprobesGEH · Traditional | IceCure Medical , Ltd. | 06/28/2024SE |
| K240106 | Histofreezer VGEH · Traditional | Cryoconcepts LP | 06/10/2024SE |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02)GEH · Traditional | Boston Scientific | 03/13/2024SE |
| K233347 | Verruca-Freeze® HGEH · Traditional | Cryosurgery, Inc. | 12/04/2023SE |
| K231661 | CryoThin Surgical System and AccessoriesGEH · Traditional | Medinux (Tianjin) Technologies Co., Ltd. | 11/27/2023SE |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)GEH · Special | Boston Scientific | 11/22/2023SE |
| K230551 | Visual-ICE Cryoablation SystemGEH · Traditional | Boston Scientific Corporation | 08/08/2023SE |
| K230599 | TargetCoolGEH · Traditional | Recensmedical, Inc. | 06/22/2023SE |
| K221897 | Hydrozid PreciseGEH · Traditional | Bibawo Medical A/S | 05/30/2023SE |
| K222356 | Claritag AdvancedGEH · Traditional | Dgi Technologies | 05/18/2023SE |
| K230271 | ISOLIS CryoprobeGEH · Traditional | Varian Medical Systems, Inc. | 03/28/2023SE |
| K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…GEH · Special | STERIS Corporation | 12/02/2022SE |
| K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…GEH · Special | STERIS Corporation | 08/18/2022SE |
| K221234 | TargetCoolGEH · Traditional | Recensmedical, Inc. | 07/22/2022SE |
| K211099 | Freezen Clear Skin Clinic Warts & TagsGEH · Traditional | Cryoconcepts LP | 06/17/2022SE |
| K220674 | TargetCoolGEH · Special | Recensmedical, Inc. | 03/31/2022SE |
| K211149 | Urethral Warming Catheter KitGEH · Traditional | Varian Medical Systems, Inc. | 01/05/2022SE |
| K212814 | C2 CryoBalloon Ablation SystemGEH · Traditional | Pentax of America, Inc. | 11/29/2021SE |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitGEH · Traditional | Nuance Medical, LLC | 10/22/2021SE |
| K201740 | HydrozidGEH · Traditional | Medilink A/S | 07/07/2021SE |
| K203481 | CryoVIVEGEH · Traditional | Recensmedical, Inc. | 05/13/2021SE |
| K210529 | Dr. Yglo Wart RemoverGEH · Traditional | Theotclab Healthcare B.V. | 05/06/2021SE |
| K201366 | ForwartsGEH · Traditional | Pronova Laboratories BV | 01/21/2021SE |
| K201183 | Vortex Radial Spray CatheterGEH · Traditional | CSA Medical, Inc. | 12/07/2020SE |
| K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…GEH · Traditional | Pentax of America, Inc. | 11/24/2020SE |
| K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle…GEH · Special | Galil Medical, Inc. | 11/02/2020SE |
| K201260 | Dermal Cooling SystemGEH · Traditional | R2 Technologies, Inc. | 09/24/2020SE |
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…GEH · Traditional | Varian Medical Systems, Inc. | 08/11/2020SE |
| K193665 | Frozen NGEH · Traditional | Yozma Bmtech Co., Ltd. | 05/28/2020SE |
| K193619 | Cry-Ac®, Cry-Ac-3®, Cry-BabyGEH · Traditional | Brymill Cryogenic Systems | 03/25/2020SE |
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…GEH · Traditional | Erbe Elektromedizin GmbH | 01/07/2020SE |
| K183213 | IceSense 3, ProSense, MultiSenseGEH · Traditional | IceCure Medical , Ltd. | 12/20/2019SE |
| K190747 | ClaritagGEH · Traditional | Dgi Technologies | 10/31/2019SE |
| K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…GEH · Traditional | Pentax Medical, A Division of Pentax of America… | 05/31/2019SE |
| K190407 | CryoLabGEH · Traditional | Cryoconcepts LP | 04/22/2019SE |
| K183601 | CryoTouchGEH · Traditional | Cryoconcepts LP | 04/18/2019SE |
| K190356 | ClariFixGEH · Special | Arrinex, Inc. | 02/26/2019SE |
| K182392 | Frozen CGEH · Traditional | B.M. Tech. Worldwide Co., Ltd. | 10/30/2018SE |
| K181741 | IceSphere 1.5 CX Cryoablation NeedleGEH · Special | Galil Medical , Ltd. | 07/30/2018SE |
| K181153 | ICEfx Cryoablation SystemGEH · Special | Galil Medical, Inc. | 05/15/2018SE |
| K180211 | FreezpointGEH · Traditional | Bovie Medical Corp. | 03/21/2018SE |
| K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…GEH · Special | AtriCure, Inc. | 02/15/2018SE |
| K163684 | C2 CryoBalloon Ablation SystemGEH · Traditional | C2 Therapeutics, Inc. | 01/23/2018SE |
| K172769 | CryOmega FlexxGEH · Traditional | Cryoconcepts LP | 11/30/2017SE |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI…GEH · Traditional | Galil Medical, Inc. | 11/21/2017SE |
| K172373 | Compound W Nitro-FreezeGEH · Traditional | Medtech Products, Inc. | 11/02/2017SE |
| K170810 | CryofosGEH · Traditional | Cryofos Medical GmbH | 09/27/2017SE |
| K172049 | CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMEDGEH · Traditional | Cry IQ AB | 08/30/2017SE |
| K171626 | truFreeze SystemGEH · Traditional | CSA Medical, Inc. | 08/30/2017SE |
| K172041 | truFreeze SystemGEH · Special | CSA Medical, Inc. | 07/27/2017SE |
| K171522 | truFreeze Rapid AV Spray KitGEH · Traditional | CSA Medical, Inc. | 07/14/2017SE |
| K171398 | Dermal Cooling SystemGEH · Traditional | R2 Dermatology ,Inc | 07/06/2017SE |
| K163244 | truFreeze SystemGEH · Traditional | CSA Medical, Inc. | 05/24/2017SE |
| K162608 | ClariFix DeviceGEH · Traditional | Arrinex, Inc. | 02/14/2017SE |
| K161202 | C2 Cryoballoon Ablation SystemGEH · Traditional | C2 Therapeutics, Inc. | 01/05/2017SE |
| K162695 | truFreeze SystemGEH · Special | CSA Medical, Inc. | 10/25/2016SE |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX LGEH · Special | Galil Medical , Ltd. | 10/11/2016SE |
| K161480 | R2 Dermal Cooling SystemGEH · Traditional | R2 Dermatology | 10/05/2016SE |
| K161294 | Compound W Wart Removal System Dual PowerGEH · Traditional | Medtech Products, Inc. | 09/15/2016SE |
| K161615 | AccurettGEH · Special | H&O Equipments, Nv/Sa | 08/23/2016SE |
| K161557 | truFreeze SystemGEH · Traditional | CSA Medical, Inc. | 07/26/2016SE |
| K161337 | CryoDose H or SimilarGEH · Traditional | Nuance Medical, LLC | 07/12/2016SE |
| K161296 | Cool RenewalGEH · Traditional | Cool Renewal, LLC | 07/06/2016SE |
| K160669 | ClariFix DeviceGEH · Traditional | Arrinex, Inc. | 06/24/2016SE |
| K160994 | C2 CryoBalloon Focal Pear CatheterGEH · Special | C2 Therapeutics, Inc. | 05/19/2016SE |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemGEH · Traditional | C2 Therapeutics, Inc. | 04/13/2016SE |
| K160273 | truFreeze SystemGEH · Traditional | Csa Medial, Inc. | 03/25/2016SE |
| K152337 | cryoFORM cryoICE cryoablation probeGEH · Traditional | AtriCure, Inc. | 03/22/2016SE |
| K153489 | Cryocare CS Surgical SystemGEH · Traditional | Healthtronics | 02/05/2016SE |
| K153541 | Coldplay CryoBalloon® Ablation SystemGEH · Special | C2 Therapeutics, Inc. | 01/07/2016SE |
| K152203 | Utermohlen Cryo ProfessionalGEH · Traditional | Koninklijke (Royal) Utermohlen | 11/06/2015SE |
| K152668 | truFreeze SystemGEH · Special | CSA Medical, Inc. | 10/14/2015SE |
| K151968 | Cryocare CS-3 Surgical System version 5GEH · Traditional | Healthtronics | 09/09/2015SE |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…GEH · Special | Galil Medical , Ltd. | 08/28/2015SE |
| K151309 | Wartie Advanced Wart Remover or other proprietary nameGEH · Traditional | Youmedical Corp BV | 08/14/2015SE |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemGEH · Special | C2 Therapeutics, Inc. | 07/07/2015SE |
| K141110 | Cryocare CS Surgical SystemGEH · Traditional | Healthtronics | 06/25/2015SE |
| K150920 | truFreeze SystemGEH · Traditional | CSA Medical, Inc. | 06/17/2015SE |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessoriesGEH · Special | Erbe USA, Inc. | 05/04/2015SE |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1GEH · Special | Galil Medical, Inc. | 03/05/2015SE |
| K143625 | truFreeze SystemGEH · Special | CSA Medical, Inc. | 01/15/2015SE |
| K142441 | cryoICE croablation probeGEH · Special | AtriCure, Inc. | 10/29/2014SE |
| K141485 | Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGEH · Special | Galil Medical , Ltd. | 07/02/2014SE |
| K133258 | Trufreeze SystemGEH · Traditional | CSA Medical, Inc. | 06/19/2014SE |
| K140314 | Wartie Wart RemoverGEH · Traditional | Yonmedical BV | 06/12/2014SE |
| K140584 | Icerod CX Cryoablation NeedleGEH · Special | Galil Medical , Ltd. | 03/31/2014SE |
| K140058 | Atricure Cryo Module SystemGEH · Special | AtriCure, Inc. | 01/24/2014SE |
| K131523 | Cryoballoon Focal Ablation SystemGEH · Special | C2 Therapeutics | 08/22/2013SE |
| K130995 | Nuance Cryo-Freeze Spray or Cryo-In-A-Can or Vandolay Freeze SprayGEH · Traditional | Nuance Medical, LLC | 06/14/2013SE |
| K130599 | Wart FreezeGEH · Special | Koninklijke Utermohlen NV | 06/05/2013SE |
| K123865 | Visual-Ice Cryoablation SystemGEH · Special | Galil Medical, Inc. | 02/06/2013SE |
| K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGEH · Traditional | Galil Medical , Ltd. | 08/28/2012SE |
| K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice)GEH · Traditional | AtriCure, Inc. | 06/06/2012SE |
| K113860 | Visual-Ice Cryoablation SystemGEH · Traditional | Galil Medical, Inc. | 03/12/2012SE |
| K113021 | Trufreeze System, Trufreeze Spray KitGEH · Traditional | CSA Medical, Inc. | 02/07/2012SE |
| K111859 | Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle MultipackGEH · Traditional | Galil Medical, Inc. | 10/07/2011SE |
| K110754 | Cryopen Cryosurgical System, K102214GEH · Traditional | Cryopen, Inc. | 09/09/2011SE |
| K112072 | Atricure Cryo Module SystemGEH · Traditional | AtriCure, Inc. | 08/03/2011SE |
| K101049 | Wart FreezeGEH · Traditional | Koninklijke Utermohlen NV | 06/23/2011SE |
| K110946 | Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation NeedleGEH · Special | Galil Medical , Ltd. | 06/21/2011SE |
| K111042 | Atricure Cryo ModuleGEH · Traditional | AtriCure, Inc. | 05/26/2011SE |
| K103310 | Cryonize TMGEH · Traditional | 3jt Enterprises, LLC | 02/09/2011SE |
| K102360 | Icesence 3GEH · Traditional | IceCure Medical , Ltd. | 11/29/2010SE |
| K102006 | CryomegaGEH · Traditional | Stc Consulting, LLC | 10/06/2010SE |
| K101825 | Cryoballoon Ablation SystemGEH · Traditional | C2 Therapeutics | 09/29/2010SE |
| K101333 | Cryocare CS Surgical SystemGEH · Traditional | Endocare, Inc. | 06/14/2010SE |
| K091721 | Cryosuccess, Model C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23GEH · Traditional | New Medical Technologies GmbH | 10/02/2009SE |
| K090978 | Uc-Care Warming SystemGEH · Traditional | UC-CARE , Ltd. | 08/10/2009SE |
| K083493 | Myoscience Cryo-TouchGEH · Traditional | Myoscience, Inc. | 03/20/2009SE |
| K082074 | Atricure CRYO1 Cryo-Ablation ProbeGEH · Traditional | AtriCure, Inc. | 03/02/2009SE |
| K073533 | Sanarus V2 Treatment SystemGEH · Special | Sanarus Medical, Inc. | 02/07/2008SE |
| K072883 | Ice-SenseGEH · Traditional | Arbel Medical , Ltd. | 12/10/2007SE |
| K072651 | Cryospray Ablation System, Model CC2-NAMGEH · Abbreviated | CSA Medical, Inc. | 12/07/2007SE |
| K072453 | Cry-Ac Tracker, Model(S) B-700T, and B-800TGEH · Traditional | Brymill Corp. | 12/03/2007SE |
| K070893 | Cryospray Ablation System, Model Cu 8407020500GEH · Special | CSA Medical, Inc. | 05/01/2007SE |
| K070482 | IsisGEH · Special | Galil Medical , Ltd. | 03/20/2007SE |
| K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600GEH · Traditional | Sanarus Medical, Inc. | 01/03/2007SE |
| K062175 | Cryocare CN2 SystemGEH · Special | Endocare, Inc. | 08/28/2006SE |
| K061510 | Sanarus Visica Treatment SystemGEH · Special | Sanarus Medical, Inc. | 07/18/2006SE |
| K060859 | Compound W Freeze Off Wart Removal SystemGEH · Special | OraSure Technologies, Inc. | 07/18/2006SE |
| K060928 | CryoshapeGEH · Traditional | Etgar Group H.M.Y.A. , Ltd. | 05/22/2006SE |
| K060390 | Seednet, Seednet Gold, Cryohit, Cryo TheraGEH · Special | Galil Medical , Ltd. | 04/27/2006SE |
| K060555 | Spraygenix Cryo Ablation SystemGEH · Traditional | Crymed Technologies, Inc. | 04/21/2006SE |
| K060279 | Cryocare CS Surgical SystemGEH · Special | Endocare, Inc. | 02/28/2006SE |
| K060144 | Seednet/Seednetgold, Cryothera and Cryo-Hit SystemsGEH · Special | Galil Medical , Ltd. | 02/13/2006SE |
| K052259 | Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406GEH · Traditional | Schering-Plough Healthcare Products, Inc. | 12/14/2005SE |
| K052530 | Seednet, Seednet Gold, Cryohit, CryotheraGEH · Traditional | Galil Medical , Ltd. | 11/18/2005SE |
| K052861 | Modification To:Sanarus Visica Treatment System , Models VS2000GEH · Special | Sanarus Medical, Inc. | 11/15/2005SE |
| K051509 | Erbe Erbokryo Ca Cryosurgical Unit & AccessoriesGEH · Traditional | Erbe USA, Inc. | 07/27/2005SE |
| K051052 | Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)GEH · Special | Galil Medical , Ltd. | 05/06/2005SE |
| K050347 | Modification to Cryocare CS Surgical SystemGEH · Traditional | Endocare, Inc. | 02/25/2005SE |
| K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)GEH · Special | Galil Medical , Ltd. | 10/14/2004SE |
| K041783 | Polar WandGEH · Traditional | Chek-Med Systems | 09/28/2004SE |
| K040809 | Crymed Cryo-AblatorGEH · Traditional | Crymed Technologies, Inc. | 05/21/2004SE |
| K032271 | Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)GEH · Traditional | Wartner USA B.V. | 09/10/2003SE |
| K031697 | Dr. Scholl's Freeze Away Wart Remover, Model 40226GEH · Traditional | Schering-Plough Healthcare Products, Inc. | 08/29/2003SE |
| K032333 | Cryocare CS Surgical SystemGEH · Traditional | Endocare, Inc. | 08/12/2003SE |
| K030838 | Wartner ProGEH · Traditional | Wartner Medical Products | 06/27/2003SE |
| K031117 | Seednet System and Seednetgold SystemGEH · Special | Galil Medical , Ltd. | 05/23/2003SE |
| K030303 | Freezor Xtra Surgical Cardiac Cryoablation Device and CCT.2 Cardiac Cardiac Cryoablation…GEH · Traditional | Cryocath Technologies, Inc. | 04/29/2003SE |
| K024009 | CryoprobeGEH · Traditional | H&O Equipments, Nv/Sa | 03/20/2003SE |
| K023487 | Histofreezer Wart Removal System or Other Proprietary NameGEH · Traditional | OraSure Technologies, Inc. | 03/20/2003SE |
| K023757 | Cryocare Surgical System, Model Cryo 20GEH · Special | Endocare, Inc. | 12/05/2002SE |
| K022314 | Sanarus Visica Treatment SystemGEH · Traditional | Sanarus Medical, Inc. | 10/15/2002SE |
| K021387 | Polar WandGEH · Traditional | Chek-Med Systems | 07/31/2002SE |
| K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3GEH · Traditional | Galil Medical , Ltd. | 07/03/2002SE |
| K021211 | Modification to Sanarus Visica Treatment SystemGEH · Special | Sanarus Medical, Inc. | 06/26/2002SE |
| K012214 | Cryopen and AccessoriesGEH · Traditional | Cimex Biotech, LLC | 04/26/2002SE |
| K020605 | Sanarus Visica Treatment SystemGEH · Traditional | Sanarus Medical, Inc. | 03/08/2002SE |
| K011708 | Modification to Wartner Wart Removal SystemGEH · Traditional | Wartner Medical Products | 02/20/2002SE |
| K011950 | Seednet, Model FP6T5, FP5T5, FP5T3GEH · Traditional | Galil Medical , Ltd. | 01/29/2002SE |
| K011074 | Cryocare Surgical SystemGEH · Traditional | Endocare, Inc. | 01/25/2002SE |
| K012497 | Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1GEH · Traditional | Galil Medical , Ltd. | 10/30/2001SE |
| K003811 | Cryocare Surgical SystemGEH · Traditional | Endocare, Inc. | 10/11/2001SE |
| K011073 | Cryoplan SystemGEH · Traditional | Cryomedical Sciences, Inc. | 08/22/2001SE |
| K010991 | Seednet, Models FP6T5, FP5T5, FP5T3GEH · Special | Galil Medical , Ltd. | 05/03/2001SE |
| K002714 | Wartner Wart Removal SystemGEH · Traditional | Wartner Medical Products | 11/28/2000SE |
| K002615 | Surgical System with CryoguideGEH · Traditional | Endocare, Inc. | 11/13/2000SE |
| K003065 | Seednet, Model EP6T5, EP5E5GEH · Special | Galil Medical , Ltd. | 10/31/2000SE |
| K993965 | Cryo-HitGEH · Traditional | Galil Medical , Ltd. | 02/18/2000SE |
| K991792 | Cryo-Mono Cryogenic System, Model Cryo-Mono with Tuf ProbeGEH · Traditional | Influence, Inc. | 08/12/1999SE |
| K991517 | Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5GEH · Traditional | Galil Medical , Ltd. | 07/27/1999SE |
| K991272 | Cryo-Hit,Models ED1TO, Epiti, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3…GEH · Traditional | Galil Medical , Ltd. | 07/12/1999SE |
| K991122 | Cryo-Mono Cryogrnic SystemGEH · Traditional | Influence, Inc. | 07/01/1999SE |
| K990877 | Histofreezer DeviceGEH · Traditional | OraSure Technologies, Inc. | 06/14/1999SE |
| K982506 | Verruca-Freeze Cryosurgery Delivery SystemGEH · Traditional | Cryosurgery, Inc. | 01/27/1999SE |
| K982280 | Cryopro Maxi and Cryopro MiniGEH · Traditional | Cortex Technology Aps | 11/25/1998SE |
| K982358 | Histofreezer DeviceGEH · Traditional | OraSure Technologies, Inc. | 10/02/1998SE |
| K982055 | Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880GEH · Traditional | Cryomedical Sciences, Inc. | 09/08/1998SE |
| K980670 | CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722GEH · Traditional | Cryomedical Sciences, Inc. | 07/17/1998SE |
| K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790GEH · Traditional | Cryomedical Sciences, Inc. | 07/17/1998SE |
| K980739 | Histofreezer/ 17% Salicylic Acid-Verruca PlantarisGEH · Traditional | OraSure Technologies, Inc. | 05/26/1998SE |
| K980110 | Endocre Cryocare Cryosurgical SystemGEH · Traditional | Endocare, Inc. | 04/10/1998SE |
| K973686 | Endocare Cryocare Cryosurgical SystemGEH · Traditional | Endocare, Inc. | 12/22/1997SE |
| K971392 | Histofreezer Verruca PlanaGEH · Traditional | OraSure Technologies, Inc. | 10/21/1997SE |
| K972662 | Cryogen Cryosurgical SystemGEH · Traditional | Cryogen, Inc. | 10/01/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2938-2026 Class II | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit… | Erbe USA Inc | 06/26/2026Open, Classified |
| Z-1568-2026 Class I | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useProbes may rupture/burst during activation | Erbe USA Inc | 02/12/2026Open, Classified |
| Z-1567-2026 Class I | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useProbes may rupture/burst during activation | Erbe USA Inc | 02/12/2026Open, Classified |
| Z-1566-2026 Class I | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401…Probes may rupture/burst during activation | Erbe USA Inc | 02/12/2026Open, Classified |
| Z-2551-2025 Class II | Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Boston Scientific Corporation | 08/18/2025Open, Classified |
| Z-2550-2025 Class II | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material…Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Boston Scientific Corporation | 08/18/2025Open, Classified |
| Z-1689-2025 Class II | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | Boston Scientific Corporation | 03/24/2025Open, Classified |
| Z-1688-2025 Class II | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | Boston Scientific Corporation | 03/24/2025Open, Classified |
| Z-1687-2025 Class II | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | Boston Scientific Corporation | 03/24/2025Open, Classified |
| Z-1686-2025 Class II | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are…Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025… | Boston Scientific Corporation | 03/24/2025Open, Classified |
| Z-1104-2025 Class II | Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item:…During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting… | New Medical Technologies Gmbh | 12/19/2024Open, Classified |
| Z-1103-2025 Class II | Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item:…During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting… | New Medical Technologies Gmbh | 12/19/2024Open, Classified |
| Z-0928-2024 Class II | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect… | AtriCure, Inc. | 11/28/2023Open, Classified |
| Z-0927-2024 Class II | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect… | AtriCure, Inc. | 11/28/2023Open, Classified |
| Z-0693-2021 Class II | IceRod" He-Thaw Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0692-2021 Class II | IceSeed" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0691-2021 Class II | IceRod" i-Thaw" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0690-2021 Class II | Five IceRod" i-Thaw" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0689-2021 Class II | Five IceSphere" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0688-2021 Class II | IceRod" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0687-2021 Class II | IceSeed" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0686-2021 Class II | IceRod" i-Thaw" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0685-2021 Class II | Three IcePearl" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0684-2021 Class II | Three IceFORCE" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0683-2021 Class II | IcePearl" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0682-2021 Class II | IceFORCE" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0681-2021 Class II | IceSeed" 1.5 MRI Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0680-2021 Class II | IceSeed" 1.5 MRI 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0679-2021 Class II | IceRod" 1.5 MRI Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0678-2021 Class II | IceRod" 1.5 MRI 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0677-2021 Class II | IceEDGE" 2.4 90p Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0676-2021 Class II | IceSeed" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0675-2021 Class II | IceSeed" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0674-2021 Class II | IceSphere" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0673-2021 Class II | IceSphere" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0672-2021 Class II | IceSphere" 1.5 S 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0671-2021 Class II | IceSphere" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0670-2021 Class II | IceSphere" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0669-2021 Class II | IceRod" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0668-2021 Class II | IceRod" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0667-2021 Class II | IceRod" 1.5 PLUS Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0666-2021 Class II | IceRod" 1.5 PLUS 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0665-2021 Class II | IceRod" 1.5 i-Thaw" Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0664-2021 Class II | IceSphere" 1.5 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0663-2021 Class II | IceRod" 1.5 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0662-2021 Class II | IcePearl" 2.1 CX L 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0661-2021 Class II | IcePearl" 2.1 CX Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0660-2021 Class II | IcePearl" 2.1 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0658-2021 Class II | IceFORCE" 2.1 CX Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |
| Z-0657-2021 Class II | IceFORCE" 2.1 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | Boston Scientific Corporation | 11/18/2020Completed |