BEUDAMED
    349 results · 23ms · Sources: EU EUDAMED, US FDA

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    EBI DYNAFIX VISION FOOTPLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code DHA·April 12, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 23, 2008

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 20, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026