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

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    I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

    FDA 510(k)
    FDA Class 2 ·Hematology

    K091319

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 9, 2026

    XIA SPINE SYSTEM HOOKS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code LRS·December 11, 2023

    REMSTAR AUTO A-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 12, 2026

    REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR

    FDA Adverse Event
    Injury ·RESPIRONICS, INC·Product code BZD·August 5, 2021

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 26, 2012

    REMSTAR PRO C-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·December 31, 2025

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    REMSTAR

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·October 22, 2024

    BIPAP PRO BIFLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 5, 2026

    S5 SYSTEM

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 27, 2010

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·September 9, 2024

    REMSTAR

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 28, 2024

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 6, 2012

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 6, 2012

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·April 10, 2025

    S5 SYSTEM

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 27, 2010