BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    LORAD LT-100 LASER TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CENTROS CHRONIC HEMODIALYSIS CATHETER SET

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

    Cytrans Granules

    FDA 510(k)
    FDA Class 2 ·Dental

    COD.712 TOP CIRC.RACC.CARDIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTN·December 15, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 7, 2013

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·February 15, 2011

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016