BEUDAMED
    33 results · 26ms · 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 ×

    FILL-IN

    FDA 510(k)
    FDA Class 2 ·Dental

    SOVEREIGN

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TORQUE INSTRUMENT, MODEL 8500

    FDA 510(k)
    FDA Unclassified ·Unknown

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013

    POSEY SITTER II ALARM

    FDA Adverse Event
    Malfunction ·J. T. POSEY COMPANY·Product code KMI·March 18, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Other ·NOVA BIOMEDICAL CORP·Product code NBW·April 18, 2008

    MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN

    FDA Adverse Event
    Injury ·MED SYSTEM, INC.·Product code BYI·September 21, 2018

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 3, 2025

    TRUENESS

    FDA Adverse Event
    Injury ·SINOCARE INC·Product code NBW·October 15, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·November 28, 2025

    TRUENESS

    FDA Adverse Event
    Injury ·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·May 29, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·March 11, 2026

    TRUENESS AIR

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·February 26, 2026

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·November 11, 2015

    6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) 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