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

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 18, 2023

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·Ge Healthcare·September 9, 2020

    Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024