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

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    EN Snare Endovascular Snare System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584055397·SA5 ITED, WL R BE SAPHIRA 5

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837088293·

    DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITESSE 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DR FOG TREATED SPONGE, STERILE

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·June 13, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 6, 2011

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014