BEUDAMED
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    Degania Silicone LTD

    Manufacturer
    🇮🇱 Israel

    Biometrix LTD

    Manufacturer
    🇮🇱 Israel·1 Importer

    The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.

    FDA Enforcement
    Class II ·Ongoing·FEMSelect Ltd·February 9, 2022

    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

    FDA Enforcement
    Class III ·Terminated·Degania Silicone, Ltd.·March 14, 2018

    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

    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

    CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870

    FDA Enforcement
    Class II ·Terminated·Biosense Webster (israel), Ltd.·September 2, 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

    Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045156

    FDA Enforcement
    Class II ·Ongoing·T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.·July 12, 2023

    Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045157

    FDA Enforcement
    Class II ·Ongoing·T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.·July 12, 2023

    BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045150

    FDA Enforcement
    Class II ·Ongoing·T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.·July 12, 2023

    BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045151

    FDA Enforcement
    Class II ·Ongoing·T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.·July 12, 2023

    Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025

    Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025

    Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025