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

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    SeaSpine Skipjack System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198277·AK3 PS Insert Trial Size 4, 18mm

    DESARA MINI

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GRAM-NEGATIVE QUICKFISH BC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD ANGIOCATH¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017

    BD ANGIOCATH¿ IV CATHETER 20G X 1.88IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FOZ·November 9, 2017

    SYNCHRO 2 GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code DQX·October 8, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

    PERSONAL COUGH & COLD STEAM INHALER

    FDA Adverse Event
    Injury ·WALGREENS EAST WEST DISTRIBUTORY COMPANY·Product code CAF·June 24, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018