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

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    DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COD.712 TOP CIRC.RACC.CARDIO

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

    IMMULISA MPO ANTIBODY ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ASAHI PTCA Guide Wire ASAHI Gaia Next

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOTINGHM SHLDR HUM HEAD 48X17 OFFSET

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWS·January 19, 2016

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 7, 2013

    2649622-1998-00625

    FDA Adverse Event
    Injury ·MPRI·February 15, 2011

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·August 8, 2014

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 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