BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    Optetrak One Logic Femoral Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLASHPAK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELLIPSE DR ICD, US

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWS·September 18, 2024

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·September 18, 2024

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2011

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·June 14, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·February 19, 2020

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019