BEUDAMED
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    Early Bird Bleed Monitoring System

    FDA UDI
    SARANAS INC.·00866532000419·

    Early Bird Bleed Monitoring System

    FDA UDI
    SARANAS INC.·00866532000402·

    EARLY BIRD BLEED MONITORING SYSTEM

    FDA Adverse Event
    Injury ·SARANAS, INC.·Product code QFJ·January 16, 2023

    EARLY BIRD BLEED MONITORING SYSTEM

    FDA Adverse Event
    Death ·SARANAS, INC.·Product code QFJ·February 26, 2023

    EARLY BIRD BLEED MONITORING SYSTEM

    FDA Adverse Event
    Injury ·SARANAS, INC.·Product code QFJ·February 26, 2023

    Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

    FDA Recall
    Open, Classified ·Saranas, Inc.·Product code QFJ·August 10, 2022

    Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

    FDA Enforcement
    Class II ·Ongoing·Saranas, Inc.·September 14, 2022