BEUDAMED
    263 results · 24ms · Sources: EU EUDAMED, US FDA

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    Ventway

    Device
    EU MDD · Eu Md Class 2b ·Inovytec Medical Solutions Ltd.·On the market·20 countries

    RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RECTOSIGHT RS 300-04

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDITECH MODEL ABPM-04

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Alfa Gate Mazen Ltd.

    Manufacturer
    🇮🇱 Israel

    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

    FDA Enforcement
    Class I ·Terminated·Alpha Omega Engineering·May 15, 2019

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    FDA Enforcement
    Class II ·Terminated·Lumenis Ltd·May 25, 2016

    MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

    FDA Enforcement
    Class II ·Ongoing·Mazor Robotics Ltd·October 18, 2023

    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

    Bond Apatite

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Augma Biomaterials·1 device

    3D Bond 1cc

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Augma Biomaterials·1 device

    3D Bond 0.5cc

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Augma Biomaterials·1 device

    SAN Light 18Gx20mm Safety Needle

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·DALI Medical Devices Ltd.·1 device

    AL-SENSE

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Peptonic Medical Israel Ltd·1 device

    Hyper-CL

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·EyeYon Medical Ltd.·1 device

    Spincare™ Portable Wound Dressing System

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Nanomedic Technologies Ltd.·1 device

    Spincare Kit

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Nanomedic Technologies Ltd.·1 device

    FFRangio System

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·CathWorks Ltd.·1 device

    3D Bond

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Augma Biomaterials·1 device

    3D Bond+

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Augma Biomaterials·1 device