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)
Top companies in GEH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2020 | K201260 | Dermal Cooling System R2 Technologies, Inc. | GEH |
| Aug 11, 2020 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice Varian Medical Systems, Inc. | GEH |
| May 28, 2020 | K193665 | Frozen N Yozma Bmtech Co., Ltd., KR | GEH |
| Mar 25, 2020 | K193619 | Cry-Ac®, Cry-Ac-3®, Cry-Baby Brymill Cryogenic Systems | GEH |
| Jan 7, 2020 | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprob Erbe Elektromedizin GmbH, DE | GEH |
| Dec 20, 2019 | K183213 | IceSense 3, ProSense, MultiSense IceCure Medical , Ltd., IL | GEH |
| Oct 31, 2019 | K190747 | Claritag Dgi Technologies | GEH |
| May 31, 2019 | K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 Cryo Pentax Medical, A Division of Pentax of America, Inc. | GEH |
| Apr 22, 2019 | K190407 | CryoLab Cryoconcepts LP | GEH |
| Apr 18, 2019 | K183601 | CryoTouch Cryoconcepts LP | GEH |
| Feb 26, 2019 | K190356 | ClariFix Arrinex, Inc. | GEH |
| Oct 30, 2018 | K182392 | Frozen C B.M. Tech. Worldwide Co., Ltd., KR | GEH |
| Jul 30, 2018 | K181741 | IceSphere 1.5 CX Cryoablation Needle Galil Medical , Ltd., IL | GEH |
| May 15, 2018 | K181153 | ICEfx Cryoablation System Galil Medical, Inc. | GEH |
| Mar 21, 2018 | K180211 | Freezpoint Bovie Medical Corp. | GEH |
| Feb 15, 2018 | K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. | GEH |
| Jan 23, 2018 | K163684 | C2 CryoBalloon Ablation System C2 Therapeutics, Inc. | GEH |
| Nov 30, 2017 | K172769 | CryOmega Flexx Cryoconcepts LP | GEH |
| Nov 21, 2017 | K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical, Inc. | GEH |
| Nov 2, 2017 | K172373 | Compound W Nitro-Freeze Medtech Products, Inc. | GEH |
| Sep 27, 2017 | K170810 | CRYOFOS Cryofos Medical GmbH, DE | GEH |
| Aug 30, 2017 | K172049 | CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED Cry IQ AB, SE | GEH |
| Aug 30, 2017 | K171626 | truFreeze System CSA Medical, Inc. | GEH |
| Jul 27, 2017 | K172041 | truFreeze System CSA Medical, Inc. | GEH |
| Jul 14, 2017 | K171522 | truFreeze Rapid AV Spray Kit CSA Medical, Inc. | GEH |
| Jul 6, 2017 | K171398 | Dermal Cooling System R2 Dermatology ,Inc | GEH |
| May 24, 2017 | K163244 | truFreeze System CSA Medical, Inc. | GEH |
| Feb 14, 2017 | K162608 | ClariFix Device Arrinex, Inc. | GEH |
| Jan 5, 2017 | K161202 | C2 Cryoballoon Ablation System C2 Therapeutics, Inc. | GEH |
| Oct 25, 2016 | K162695 | truFreeze System CSA Medical, Inc. | GEH |
| Oct 11, 2016 | K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L Galil Medical , Ltd., IL | GEH |
| Oct 5, 2016 | K161480 | R2 Dermal Cooling System R2 Dermatology | GEH |
| Sep 15, 2016 | K161294 | Compound W Wart Removal System Dual Power Medtech Products, Inc. | GEH |
| Aug 23, 2016 | K161615 | Accurett H&O Equipments, Nv/Sa, BE | GEH |
| Jul 26, 2016 | K161557 | truFreeze System CSA Medical, Inc. | GEH |
| Jul 12, 2016 | K161337 | CryoDose H or Similar Nuance Medical, LLC | GEH |
| Jul 6, 2016 | K161296 | Cool Renewal Cool Renewal, LLC | GEH |
| Jun 24, 2016 | K160669 | ClariFix Device Arrinex, Inc. | GEH |
| May 19, 2016 | K160994 | C2 CryoBalloon Focal Pear Catheter C2 Therapeutics, Inc. | GEH |
| Apr 13, 2016 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System C2 Therapeutics, Inc. | GEH |
| Mar 25, 2016 | K160273 | truFreeze System Csa Medial, Inc. | GEH |
| Mar 22, 2016 | K152337 | cryoFORM cryoICE cryoablation probe AtriCure, Inc. | GEH |
| Feb 5, 2016 | K153489 | Cryocare CS Surgical System Healthtronics | GEH |
| Jan 7, 2016 | K153541 | Coldplay CryoBalloon® Ablation System C2 Therapeutics, Inc. | GEH |
| Nov 6, 2015 | K152203 | UTERMOHLEN CRYO PROFESSIONAL Koninklijke (Royal) Utermohlen, NL | GEH |
| Oct 14, 2015 | K152668 | truFreeze System CSA Medical, Inc. | GEH |
| Sep 9, 2015 | K151968 | Cryocare CS-3 Surgical System version 5 Healthtronics | GEH |
| Aug 28, 2015 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoab Galil Medical , Ltd., IL | GEH |
| Aug 14, 2015 | K151309 | Wartie Advanced Wart Remover or other proprietary name Youmedical Corp BV, NL | GEH |
| Jul 7, 2015 | K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System C2 Therapeutics, Inc. | GEH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.