BEUDAMED
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    CAP, TAMPER PROOF PLASTIC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838098909·SmartPath to dStream integrates dStream archite...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707067511·LIGATING MODULES 1,3mm TRANSPARENT

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111310201·JACKSON TUBE IMP SHORT #3 STL

    Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    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

    NOX T3, NOXTURNAL (PC APPLICATION)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    URINARY DRAINAGE BAG 2D9017

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    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

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 30, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·February 12, 2008

    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

    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    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