BEUDAMED
    15 results · 72ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    NRT X-RAY A/S

    FDA registration
    NRT X-RAY A/S·2 products·🇩🇰 Denmark

    GE PRECISION MPI

    FDA Adverse Event
    Malfunction ·NRT X-RAY A/S·Product code JAA·May 4, 2020

    INTELLI-C

    FDA Adverse Event
    Malfunction ·NRT X-RAY A/S·Product code OWB·February 28, 2023

    INTELLI-C, FOOTREST

    FDA Adverse Event
    Malfunction ·NRT X-RAY A/S·Product code OWB·January 21, 2022

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·May 15, 2024

    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·February 2, 2022

    Intelli-C, Left side suspended Tabletop, REF: 03400010

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

    Intelli-C, Left side suspended Tabletop, REF: 03400010

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023

    Intelli-C, Right side suspended Tabletop, REF: 03400000

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023

    PRECISION MPI

    FDA Adverse Event
    Malfunction ·NRT - NORDISK RONTGEN TEKNIK A/S·Product code JAA·April 8, 2020

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024

    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 BIRKEGAARDSVEJ 16 Hasselager Denmark·Product code OWB·January 21, 2022

    GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.

    FDA Recall
    Terminated ·Regulatory Insight, Inc·Product code OWB·July 1, 2008

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·December 29, 2020