BEUDAMED
    19 results · 19ms · Sources: EU EUDAMED, US FDA

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    DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989051629·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 21

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707032038·WEB 1ST MOLAR BANDS n.LR 21

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600211·Max. 2. Molar band W-Fit left 21

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690120896·A/P FEMORAL CUTTING BLOCK SZ 1

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600210051·Max. 2. Molar band W-Fit left 21

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600210101·Max. 2. Molar band W-Fit left 21

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR88600210501·Max. 2. Molar band W-Fit left 21

    NON ADHERANT NEUROLOGICAL SPONGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    Varian Sterilization Boxes

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARELINK

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

    CURLIN ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·October 31, 2012

    ENDOVIVE¿ STANDARD PEG KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 22, 2015

    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

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012