FDA.reportPublic FDA data

General cryosurgical system, cryogen gas, mechanical

Definition
An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.
GUDID devices
175
Last updated
2026-10-13 01:09:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10840143912788cryoICE®ATRICURE, INC.CRYO22026-09-29
10840143912795cryoICE®ATRICURE, INC.CRYO32026-09-29
10840143912801cryoICE® cryoFORM™ATRICURE, INC.CRYOF2026-09-29
00087701190803Good Neighbor Pharmacy Freeze Skin Tag RemoverAmerisourcebergen Drug Corporation1500-11112026-09-26
00860001513745Verruca-Freeze H+CryoSurgery, Inc.VFHP1M2026-07-31
00860001513752Verruca-Freeze H+CryoSurgery, Inc.VFHP1A2026-07-31
00860001513769Verruca-Freeze H+CryoSurgery, Inc.VFHP1R2026-07-31
00860001513790Verruca-Freeze H+CryoSurgery, Inc.VFHP2M2026-07-31
08800073100018TargetCoolRecensMedical, Inc.RM-DT02W2021-06-25
08800073100049TargetCoolRecensMedical, Inc.RM-DC04U2022-11-29
08800073100148TargetCool-eRecensMedical, Inc.RH-PD06W2026-05-14
10840143902666cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902673cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902680cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902697cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902703cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902710cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902727cryoICE® SystemATRICURE, INC.A0011502026-05-27
10840143902734cryoICE® SystemATRICURE, INC.A0011502026-05-27
30840143904343cryoICE® SystemATRICURE, INC.CMF12026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.ACM12026-05-27
00011822615396Rite AidOrasure Technologies, Inc.03615392016-09-27
00050428256411CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED2740892016-11-30
00050428333891CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED8328642016-11-30
00304040020364Henry ScheinHENRY SCHEIN, INC.11268702016-09-24
00311917056203WalgreensWALGREEN CO.8694322025-01-16
00311917182216Well at WalgreensWALGREEN CO.9304482016-08-15
00608337000559HistofreezerOrasure Technologies, Inc.1001-03752016-09-15
00608337360103HistofreezerOrasure Technologies, Inc.1001-02952016-09-15
00608337365108HistofreezerOrasure Technologies, Inc.1001-02942016-09-15
00608337402100HistofreezerOrasure Technologies, Inc.1001-02932016-09-15
00724995199203truFreezeUS EndoscopyACCCC3CDT052022-05-04
00724995199210truFreezeUS Endoscopy20001812022-05-04
00724995199227truFreezeUS Endoscopy20001772022-05-04
00724995199234truFreezeUS Endoscopy20003602021-12-17
00724995199289truFreezeUS EndoscopyCO84070305012022-05-04
00724995199326truFreezeUS Endoscopy20005162022-05-04
00724995199333truFreezeUS Endoscopy20001842022-05-04
00850077006081HistofreezerCRYOCONCEPTS, LP1001-02932020-09-22
00850077006098HistofreezerCRYOCONCEPTS, LP1001-02942020-06-24
00850077006104HistofreezerCRYOCONCEPTS, LP1001-02952020-09-22
00850077006111HistofreezerCRYOCONCEPTS, LP1001-03362020-09-22
00850077006340Histofreezer FLEXCRYOCONCEPTS, LP200-30502020-09-13
00850077006357Histofreezer FLEXCRYOCONCEPTS, LP200-40512020-09-13
00850077006364Histofreezer FLEXCRYOCONCEPTS, LP200-50522020-09-13
10381780171898Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335102016-08-25
10381780171904Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335112016-08-16
10381780171911Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335122016-08-16
10381780171928Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335132016-08-16
10381780171935Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335142016-08-16
10381780171942Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335152016-08-16
10381780171959Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335162016-09-08
10381780171966Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335172016-09-08
10381780171973Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335182016-08-23
10381780171980Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335192016-08-16
10381780171997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335202016-08-16
10381780172000Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335212016-08-16
10381780177098Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATION335222016-08-16
10612479220093McKessonMCKESSON MEDICAL-SURGICAL INC.140-01002017-08-02
10723797806446Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLC115mL Mist2025-12-15
10723797807443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLC115mL Medium Stream2025-12-15
10723797809447Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLC35mL Mist2025-12-15
10840143902307cryoICE Cryoablation SystemATRICURE, INC.CRYO22021-01-08
10840143902321AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.CRYO22021-01-08
10840143902383cryoICE Cryoablation SystemATRICURE, INC.CRYO32021-01-08
10840143902420AtriCure cryoICE Cryoablation System (CRYO3)ATRICURE, INC.CRYO32021-01-08
10840143902468cryoICE Cryoablation SystemATRICURE, INC.CRYOF2021-01-08
10840143902505AtriCure cryoICE cryoFORM Cryoablation System (CRYOF)ATRICURE, INC.CRYOF2021-01-08
10840143902543AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.CRYOS2021-01-08
10840143902550AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.CRYOS-L 2021-01-08
10840143912863AtriCure cryoICE cryoXTATRICURE, INC.CRYOXT2025-04-25
10840143917004AtriCure cryoICE cryoXTATRICURE, INC.CRYOXT2025-10-01
15407008482104CryoProbe™H & O Equipments SA8g cartridges for CryoProbe2021-08-27
15407008482302CryoProbe™H & O Equipments SA16g cartridges for CryoProbe2021-06-02
15407008484009Freezpen®H & O Equipments SA8g cartridges for Freezpen2021-08-27
15407008484108Freezpen®H & O Equipments SA8g cartridges for Freezpen2021-09-21
15407008484207Freezpen®H & O Equipments SA16g cartridges for Freezpen2021-08-27
15407008484306Freezpen®H & O Equipments SA16g cartridges for Freezpen2021-09-21
15407008484504Freezpen®H & O Equipments SA35g cartridges for Freezpen2020-09-16
15407008486003Accurett®H & O Equipments SA8g cartridges for Accurett2021-09-21