BEUDAMED
    24 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Country: Norway × Clear all

    Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Technologies AS·September 4, 2024

    GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 17, 2024

    GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 17, 2024

    Molift Smart 150

    FDA Enforcement
    Class II ·Terminated·Moller Vital·May 29, 2013

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    FDA Enforcement
    Class II ·Terminated·Medistim Asa·March 7, 2018

    Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants

    FDA Enforcement
    Class II ·Terminated·Moller Vital·August 3, 2016

    Molift Smart 150

    FDA Enforcement
    Class II ·Terminated·Moller Vital·May 29, 2013

    nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018

    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 13, 2018

    fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·September 19, 2018

    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 13, 2018

    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018

    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 13, 2018

    nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018

    Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003

    FDA Enforcement
    Class II ·Ongoing·Moller Vital·May 22, 2019

    Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021

    FDA Enforcement
    Class II ·Ongoing·Moller Vital·May 22, 2019

    Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.

    FDA Enforcement
    Class II ·Ongoing·Abbott Diagnostics Technologies AS·June 10, 2020

    GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)

    FDA Enforcement
    Class II ·Terminated·Gentian AS·October 21, 2020

    GE Healthcare Vivid S70N, ultrasound device

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 19, 2023

    GE Healthcare Vivid S60N, ultrasound device

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 19, 2023