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

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    SecurAcath

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022

    CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022

    CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    M2A 1 PC SHELL 38MMX60MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 20, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MTA·May 5, 2011

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023