BEUDAMED
    3 results · 39ms · Sources: EU EUDAMED, US FDA

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    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code DWF·October 14, 2021

    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code KFM·June 30, 2023

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023