1,525 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.
FDA Recall
Terminated
·Healthtronics, Inc.·Product code GEH·December 20, 2012
SurgiFrost Cryosurgical Probes
FDA Recall
Terminated
·Endocare Inc·Product code GEH·October 25, 2002
Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System Model: 900034.
FDA Recall
Terminated
·Cooper Surgical, Inc.·Product code GEH·September 29, 2009
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code GEH·July 15, 2020
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
FDA Recall
Terminated
·PENTAX of America Inc·Product code GEH·March 30, 2018
Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218
FDA Recall
Terminated
·Wallach Surgical Devices, Inc.·Product code GEH·June 6, 2007
Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
FDA Recall
Terminated
·Endocare, Division Of Healthtronics·Product code GEH·November 4, 2010
Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient;s target organ. Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Presice has the following specific indications: " Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH"); " Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention); " Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.); " Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia); " General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma); * ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); " Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); * Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Presice system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
FDA Recall
Terminated
·Galil Medical, Inc.·Product code GEH·December 20, 2010
Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code GEH·June 4, 2020
Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System Model: 900010.
FDA Recall
Terminated
·Cooper Surgical, Inc.·Product code GEH·September 29, 2009
Wallach LL100 Cryosurgical Freezer Atom CO2 System Model: 900036.
FDA Recall
Terminated
·Cooper Surgical, Inc.·Product code GEH·September 29, 2009
Wallach LL100 Cryosurgical Freezer CO2 System Model: 9000002X.
FDA Recall
Terminated
·Cooper Surgical, Inc.·Product code GEH·September 29, 2009
CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
FDA Recall
Terminated
·Healthtronics, Inc.·Product code GEH·February 27, 2012
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
FDA Recall
Terminated
·PENTAX of America Inc·Product code GEH·December 3, 2018
Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
FDA Recall
Terminated
·Wallach Surgical Devices, Inc.·Product code GEH·June 6, 2007
V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.
FDA Recall
Terminated
·Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.·Product code GEH·December 5, 2008
Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
FDA Recall
Terminated
·Galil Medical, Inc.·Product code GEH·July 20, 2012
Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code GEH·June 4, 2020
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code GEH·June 4, 2020
Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue.
FDA Recall
Terminated
·Galil Medical·Product code GEH·December 11, 2007