BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Fifty50

    FDA UDI
    i-SENS, Inc.·00892896000017·Fifty50 Blood Glucose Test Strip

    NICOLET WIRELESS EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    RAINBOW ADHESIVE CO-OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 15, 2011

    HARMONIC ACE 23 CM

    FDA Adverse Event
    Injury ·EHTICON ENDO-SURGERY, LLC.·Product code LFL·September 17, 2008

    VERSAFITCUP ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 3, 2018

    MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016