BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    6450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750005536·6450 V2 XSM MASK SPU HG/FLEXMA

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837046002·Plateau-LO Short Spacer Caddy, 12 Degree

    PRISMAFLEX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    XIA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·April 11, 2014

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 2, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 15, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·December 23, 2013

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 17, 2011

    9617604-2008-00068

    FDA Adverse Event
    Malfunction ·Product code FPA·May 29, 2008

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·January 10, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·January 3, 2014

    PRISMAFLEX

    FDA Adverse Event
    GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·August 13, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·January 10, 2014

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021