BEUDAMED
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    HYCEL COUNTER 222

    FDA 510(k)
    FDA Class 2 ·Hematology

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838098275·Enables trained physicians to obtain cross-sect...

    Riptide Aspiration System (React 71 Catheter)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·October 18, 2021

    EBI SPINELINK - II SPINAL FIXATION SYSTEM

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

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·October 11, 2012

    ULTRACISION HARMONIC SCALPEL HAND PIECE

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

    Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315

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

    Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

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

    Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

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

    Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

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

    Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

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

    Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315

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

    Ingenia 1.5T -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) 782115 2) 782101 3) 782140

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

    Ingenia 1.5T -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) 782115 2) 782101 3) 782140

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