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

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    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    FDA Recall
    Open, Classified ·Lumicell, Inc.·Product code SAW·July 31, 2025