BEUDAMED
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    NIDEK AC-2000 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989051520·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 11

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707031932·WEB 1ST MOLAR BANDS n.LR 11

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981137472·Inserter With Stop

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012366·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024552388·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024552333·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024552289·

    MIIG SR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    H-Max S stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHORELINE ACS

    FDA Adverse Event
    Malfunction ·SEASPINE ORTHOPEDICS CORPORATION·Product code MAX·January 10, 2025

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    ETS-FLEX - ENDOSCOPIC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 7, 2010

    IAB: 8 FR - 40 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·December 4, 2012

    IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018

    IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 18, 2017