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

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    IS-III active System

    FDA 510(k)
    FDA Class 2 ·Dental

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361480·Integra® Miltex® Berke Ptosis Forceps

    SAFEFLO VENA CAVA FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·June 21, 2013

    ALLEGRETTO WAVE

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·July 22, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 30, 2008

    ARCHITECT C8000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 26, 2021

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·April 19, 2021

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·December 11, 2018

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·November 30, 2018

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·December 3, 2018

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·November 27, 2018

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·September 17, 2020

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·December 7, 2018

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·May 29, 2019

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·March 3, 2020

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021