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

    EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·November 9, 2022

    EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·December 23, 2020

    3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

    FDA Enforcement
    Class II ·Ongoing·3M Company - Health Care Business·February 28, 2024

    3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L

    FDA Enforcement
    Class II ·Ongoing·3M Company - Health Care Business·February 28, 2024