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

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

    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110

    FDA Enforcement
    Class II ·Ongoing·CardioQuip, LLC·October 13, 2021

    NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E

    FDA Enforcement
    Class II ·Ongoing·Mc3 Inc·March 27, 2024

    NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

    FDA Enforcement
    Class II ·Ongoing·Mc3 Inc·March 27, 2024

    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

    FDA Enforcement
    Class II ·Ongoing·Ace Surgical Supply Co., Inc.·March 30, 2022