BEUDAMED
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    FUL-VUE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838099746·Upgrade to the Elition X for our customers havi...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111310850·JACKSON TUBE IMP SHORT #8 STL

    Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

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

    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

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

    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

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

    Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

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

    armor LC

    FDA 510(k)
    FDA Class 1 ·Dental

    XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNKNOWN HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·April 30, 2014

    UNKNOWN ENDO CATCH

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GCJ·October 3, 2012

    ULTRACISION HARMONIC SCALPEL HAND PIECE

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

    Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 14, 2022

    Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

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

    Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·November 22, 2022

    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 12, 2023

    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 12, 2023

    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

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

    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

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

    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 16, 2023