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

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    Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PediatrOS RigidTack/FlexTack

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAF-T-SYRINGE/SAF-T-NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·September 16, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·December 3, 2008

    T4 POWER PACK

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code LYU·July 29, 2013

    Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·March 21, 2018