BEUDAMED
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    LAP SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838098336·Ingenia Elition X

    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 4, 2026

    Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

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

    Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

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

    Ingenia Elition X- 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) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136

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

    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

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

    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

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

    CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CarriGen PF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ingenia Elition X- 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) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136

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

    GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LPH·January 19, 2018

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 27, 2007

    33 HEMORRHOID STAPLER 4.8MM STAPLES

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·October 3, 2012

    Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136

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

    Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136

    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