BEUDAMED
    22 results · 36ms · Sources: EU EUDAMED, US FDA

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    MODIFIED CHERNE CAD DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SWANSON

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420129222·

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989051568·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 15

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707031970·WEB 1ST MOLAR BANDS n.LR 15

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932809·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931703·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930607·Percutaneous Transluminal Angioplasty Balloon C...

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012380·

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·FLUORO-CEP{R} ESTROGEN ASSAY REAGENT

    Pure Vu

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANTERIS Thoracolumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·FLUORO-CEP{R} ESTROGEN ASSAY REAGENT

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·FLUORO-CEP{R} ESTROGEN ASSAY REAGENT

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 4, 2012

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·September 17, 2010

    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

    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