Product code GEH— General, Plastic Surgery
truFreeze System
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 263
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GEH
1–100 of 263- K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
- K260377 — XSense Cryoablation System with CryoProbes
- K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
- K251524 — Dr. Yglo Skin Tag Remover
- K250742 — Focused Cryotherapy System
- K253000 — CryoFreeze Wart and Skin Tag Remover
- K253114 — TargetCool (RM-DT02W)
- K253348 — TargetCool-e
- K252903 — Verruca-Freeze H Plus
- K251493 — Skin Clinic Freeze Point for Warts and Skin Tags
- K242932 — Skin Clinic Nitro Clear Wart Remover
- K243487 — CryoFreeze Wart and Skin Tag Remover
- K243042 — Co-Ablation System with Sterile Co-Ablation Probe
- K242288 — Advanced Cryo Wart Remover
- K243454 — Verruca-Freeze H
- K242803 — Compound W Skin Tag Remover
- K242625 — Freeze Point & Private Label Versions
- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
- K240776 — Celsio Flexible Cryocatheter System
- K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
- K240892 — XSense Cryoablation System with Cryoprobes
- K240106 — Histofreezer V
- K234002 — ICEfx Cryoablation System (FPRCH8000-02)
- K233347 — Verruca-Freeze® H
- K231661 — CryoThin Surgical System and Accessories
- K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- K230551 — Visual-ICE Cryoablation System
- K230599 — TargetCool
- K221897 — Hydrozid Precise
- K222356 — Claritag Advanced
- K230271 — ISOLIS Cryoprobe
- K223369 — truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
- K222272 — truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
- K221234 — TargetCool
- K211099 — Freezen Clear Skin Clinic Warts & Tags
- K220674 — TargetCool
- K211149 — Urethral Warming Catheter Kit
- K212814 — C2 CryoBalloon Ablation System
- K210310 — CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
- K201740 — Hydrozid
- K203481 — CryoVIVE
- K210529 — Dr. Yglo Wart Remover
- K201366 — Forwarts
- K201183 — Vortex Radial Spray Catheter
- K203024 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- K203032 — IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
- K201260 — Dermal Cooling System
- K201588 — CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
- K193665 — Frozen N
- K193619 — Cry-Ac®, Cry-Ac-3®, Cry-Baby
- K190651 — ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
- K183213 — IceSense 3, ProSense, MultiSense
- K190747 — Claritag
- K190194 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- K190407 — CryoLab
- K183601 — CryoTouch
- K190356 — ClariFix
- K182392 — Frozen C
- K181741 — IceSphere 1.5 CX Cryoablation Needle
- K181153 — ICEfx Cryoablation System
- K180211 — Freezpoint
- K180137 — AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
- K163684 — C2 CryoBalloon Ablation System
- K172769 — CryOmega Flexx
- K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
- K172373 — Compound W Nitro-Freeze
- K170810 — CRYOFOS
- K171626 — truFreeze System
- K172049 — CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
- K172041 — truFreeze System
- K171522 — truFreeze Rapid AV Spray Kit
- K171398 — Dermal Cooling System
- K163244 — truFreeze System
- K162608 — ClariFix Device
- K161202 — C2 Cryoballoon Ablation System
- K162695 — truFreeze System
- K162599 — IcePearl 2.1 CX L, IceForce 2.1 CX L
- K161480 — R2 Dermal Cooling System
- K161294 — Compound W Wart Removal System Dual Power
- K161615 — Accurett
- K161557 — truFreeze System
- K161337 — CryoDose H or Similar
- K161296 — Cool Renewal
- K160669 — ClariFix Device
- K160994 — C2 CryoBalloon Focal Pear Catheter
- K152329 — Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
- K160273 — truFreeze System
- K152337 — cryoFORM cryoICE cryoablation probe
- K153489 — Cryocare CS Surgical System
- K153541 — Coldplay CryoBalloon® Ablation System
- K152203 — UTERMOHLEN CRYO PROFESSIONAL
- K152668 — truFreeze System
- K151968 — Cryocare CS-3 Surgical System version 5
- K152133 — IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
- K151309 — Wartie Advanced Wart Remover or other proprietary name
- K151054 — Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
- K141110 — CRYOCARE CS SURGICAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.