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

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    STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127352·Apex Revision Knee System-Revision Tibia Reamer...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036026905·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690194910·Apex Revision Knee System-Revision Tibia Reamer...

    NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

    UNIFY CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013

    ACCUTORR V MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·August 18, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·May 5, 2011

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024