BEUDAMED
    30 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Country: Israel × Clear all

    GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    SMV DSI, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    MAXXUS, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    SMV BodyTrack, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    SMV DSX New Line, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025

    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

    FDA Enforcement
    Class II ·Terminated·Degania Silicone, Ltd.·January 22, 2020

    Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

    FDA Enforcement
    Class II ·Terminated·Paltop Advanced Dental Solutions Ltd·October 9, 2019

    Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

    FDA Enforcement
    Class II ·Terminated·Paltop Advanced Dental Solutions Ltd·January 29, 2020

    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

    FDA Enforcement
    Class II ·Terminated·Mazor Robotics Ltd·January 1, 2020

    McKesson Cardiology Hemo

    FDA Enforcement
    Class II ·Terminated·Change Healthcare Israel Ltd.·June 5, 2019

    Horizon Cardiology Hemo

    FDA Enforcement
    Class II ·Terminated·Change Healthcare Israel Ltd.·June 5, 2019

    Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·July 16, 2025

    Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Waismed Ltd.·July 23, 2025

    McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.

    FDA Enforcement
    Class II ·Terminated·McKesson Israel Ltd.·September 12, 2018