BEUDAMED
    39 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026

    GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022