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

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    SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR

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

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981669·anteriors; shade D3 light; mould UL2

    IMPROVED COMFORT-FIT NIGHTGUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    ConvertX Biliary Stent System

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

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 27, 2013

    STRAIGHT RASP HANDLES

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHAH·Product code LXH·January 12, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 5, 2014

    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