BEUDAMED
    36 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Pump 381 Pump Set (US); Product Code: 1000080;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 Set AU; Product Code: 1000361;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Smart Assist Set; Product Code: 1000402;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Pump 371 14F LT CMR Set; Product Code: 0048-0045;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·January 17, 2024

    Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·January 17, 2024

    Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·January 17, 2024