BEUDAMED
    58 results · 32ms · Sources: EU EUDAMED, US FDA

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    ALCON MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    SAFESET TRANSPAC IV

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DRS·November 28, 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

    CODMAN VPV SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF·Product code JXG·January 28, 2015