BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    SOMATOM Pro.Pulse

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION

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

    MELYS ATRIAL FIBRILLATION SCREENING MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·May 7, 2021

    DRILL (STAINLESS STEEL)

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code HTW·April 24, 2019

    ACRYSERT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code KYB·November 14, 2008

    MAHURKAR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MPB·August 26, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code ITJ·October 4, 2012

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014