BEUDAMED
    25 results · 24ms · Sources: EU EUDAMED, US FDA

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    IQQA-CHEST SOFTWARE PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CEREC VITABLOCKS MK2

    FDA 510(k)
    FDA Class 2 ·Dental

    AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·March 11, 2008

    BHR MODULAR HEAD 46MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·December 17, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·May 7, 2009

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC·Product code KWP·August 11, 2009

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·March 19, 2010

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 2, 2013

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 1, 2016

    NC QUANTUM APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 9, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·May 8, 2008

    TELIGEN

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

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 6, 2013

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·November 2, 2009

    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·September 3, 2014