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

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    D-STORM 810NM, D-STORM 980NM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    D-SPECT Scanner, D-SPECT L Scanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    TrueDent-D Yellow

    Device
    EU MDR · Eu Md Class 1 ·Stratasys Ltd.·On the market·13 countries

    TrueDent-D Magenta

    Device
    EU MDR · Eu Md Class 1 ·Stratasys Ltd.·On the market·13 countries

    TrueDent-D Cyan

    Device
    EU MDR · Eu Md Class 1 ·Stratasys Ltd.·On the market·13 countries

    TrueDent-D White

    Device
    EU MDR · Eu Md Class 1 ·Stratasys Ltd.·On the market·13 countries

    TrueDent-D Clear

    Device
    EU MDR · Eu Md Class 1 ·Stratasys Ltd.·On the market·13 countries

    D-SPECT CARDIO

    Device
    EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·8 countries

    D-SPECT VISTA

    Device
    EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·8 countries

    D-SPECT CARDIAC SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    D-SPECT Processing and Reviewing Workstation

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TrueDent-D

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Stratasys Ltd.·5 devices

    D-SPECT

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·2 devices

    LevMed Dedicated ECG Electrode Belt with Straps. D-Type with Screws Connector (ARs-DT-WS-LM

    Device
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·On the market·32 countries

    LevMed Dedicated ECG Electrode Belt with Handles. D-Type With Screws Connector (ARh-DT-WS-LM)

    Device
    EU MDR · Eu Md Class 1 ·Levmed Ltd.·On the market·32 countries

    GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

    GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

    GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023