BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    FDA UDI
    Smith & Nephew, Inc.·03596010103994·SUTURE WIRE 35 GA

    MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYLFIRM X

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

    IN00087 CLERMONT FERRAND PH

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DWF·March 7, 2014

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014

    LONG 45 ENDOCUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 23, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    INSPIRE 6F HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025