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

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    PINE Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517629616·CoRoent Ant TLIF Ti, 12x10x28mm 15°

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540366771·SCREWDRIVER HANDLE, UNIVERSAL

    K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CMA CEREBRAL TISSUE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·November 3, 2008

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·August 16, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025