BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    Cortisol Saliva Luminescence Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171029427·PESSARY, RING #4, W/SUPPORT, 2.75"

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2026

    RINGLOC-X E1 H/W 56/32MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·April 11, 2025

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    TRIDENT PSL HA CLUSTER 52MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·June 23, 2011

    24G X 0.75IN (0.7 X 19 MM) ANGIOCATH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 2, 2019

    BD ANGIOCATH¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·March 7, 2019

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 14, 2016

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016