BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    PACE *AID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEONE GOLD PRIMARY 6-FILE STER 25MM

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·August 3, 2023

    Compress and Mini Compress Anti-Rotation Spindles

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRE-LOADED ULTRAFIX RC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·January 3, 2012

    PROTAPER GOLD S1 21MM STER

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·July 12, 2023

    WAVEONE GOLD PRIMARY 6-FILE STER 25MM

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·July 12, 2023

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAW·May 15, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    CRYSTALLINE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010

    EQUINOXE PRESERVE STEM 6MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code PHX·April 25, 2024

    Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014