BEUDAMED
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    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

    JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    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

    Five IceRod" i-Thaw" Prostate Cryoablation Kit

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020

    IceSphere" 1.5 90 Cryoablation Needle

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020

    IceRod" Prostate Cryoablation Kit

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020

    Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·August 18, 2025

    ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code GEH·August 18, 2025

    Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use

    FDA Recall
    Open, Classified ·Erbe USA Inc·Product code GEH·February 12, 2026

    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

    IceRod" i-Thaw" Prostate Cryoablation Kit

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020

    IceSeed" 1.5 MRI Cryoablation Needle

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020