BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

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    LUPO-TEC

    FDA 510(k)
    FDA Class 2 ·Immunology

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838105805·SmartPath to dStream integrates dStream archite...

    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 2, 2024

    SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    MAGNETOM Sola

    FDA 510(k)
    FDA Class 2 ·Radiology

    SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    EBI SPINELINK - II SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code NKB·April 30, 2014

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·October 11, 2012

    INCISOR, 4.5, DISP, BLADE , EP-1

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HAB·May 19, 2015

    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 7, 2024

    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNI·January 3, 2024

    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 24, 2024