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

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    TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013

    BELMONT UNIT, MODEL 2000 SERIES

    FDA 510(k)
    FDA Class 1 ·Dental

    COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)

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

    VPV SYSTEM

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF MEDOS·Product code JXG·January 6, 2014

    CODMAN VIPV SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·November 5, 2010

    CODMAN VPV SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·January 11, 2018

    NIM-ECLIPSE® ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016

    CODMAN VPV SYSTEM

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·October 1, 2016

    BIPAP AUTO M-SERIES

    FDA Adverse Event
    Death ·RESPIRONICS, INC·Product code BZD·July 11, 2012

    BIPAP AUTO SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 9, 2022

    BIPAP AUTO SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 14, 2022

    BIPAP AUTO BIFLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 14, 2022

    CODMAN VPV SYSTEM

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·November 12, 2015

    BIPAP AUTO SERIES ASSY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 31, 2022

    BIPAP AUTO SERIES

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 14, 2022

    BIPAP AUTO SERIES ASSY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code BZD·March 31, 2022

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    FDA Enforcement
    Class II ·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017

    CODMAN VPV SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC, MEDOS S.A.·Product code JXG·October 11, 2010

    CODMAN VPV SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·August 16, 2017