BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    STAT-CRIT HEMATOCRIT MEASURING INSTRU

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPIRALFUSE PERIPHERAL INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKNOWN HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 9, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025