BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    CystoSure Plus Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    HOYA IS INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GC ORAL MOISTURIZING GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    CARTIVA IMPLANT

    FDA Adverse Event
    Injury ·CARTIVA, INC·Product code PNW·November 13, 2020

    CARTIVA IMPLANT

    FDA Adverse Event
    Injury ·CARTIVA, INC·Product code PNW·November 9, 2020

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 21, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 21, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 6, 2014

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020