BEUDAMED
    5 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·July 3, 2024

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 21, 2025

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Enforcement
    Class II ·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024