BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    NAMIC COURNAND STYLE INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Young INFINITY Cordless Handpiece System

    FDA 510(k)
    FDA Class 1 ·Dental

    POLARIS BE RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2014

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 2012

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·June 26, 2015

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024