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

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    ECG recorder and Arrhythmia Detector

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·August 16, 2012

    ORTHO ANCHOR SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    COLGATE DESENSITIZING DENTAL CREAM

    FDA 510(k)
    FDA Class 2 ·Dental

    3006948883-2019-00166

    FDA Adverse Event
    Malfunction ·March 8, 2019

    MALLINKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·August 17, 2010

    STERILIZED CONVENIENCE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code KDD·October 10, 2014

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·June 6, 2013

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 23, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 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