BEUDAMED
    59 results · 26ms · Sources: EU EUDAMED, US FDA

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    Q Interbody Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aspire Cristalle

    FDA 510(k)
    FDA Class 2 ·Radiology

    Crosstella RX Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    LIFEBEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 4, 2014

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·July 29, 2013

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 2, 2021

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 9, 2019

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 11, 2024

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·February 20, 2020

    SENRI

    FDA Adverse Event
    Injury ·KANEKA·Product code LIT·March 12, 2019

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 6, 2025

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·December 24, 2025

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

    18 SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 19, 2025

    SENRI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2025