BEUDAMED
    25 results · 19ms · Sources: EU EUDAMED, US FDA

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    ToxiSeal™ Vial Adaptor with External Flip Balloon

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WAVELIGHT FS200 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    SUBQ

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·November 10, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEATLHCARE - ANDOVER·Product code MKJ·August 9, 2011

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 22, 2013

    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

    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

    BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 24, 2026

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·October 20, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·November 19, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC.·Product code NBW·October 10, 2025

    TRUENESS

    FDA Adverse Event
    Malfunction ·SINOCARE INC·Product code NBW·April 28, 2026