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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·July 19, 2017

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 19, 2013