BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Water Container (MAJ-901); Water Container (MAJ-902)

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

    IDI-MRSA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DuraSheath Introducer Sheath System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 7, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 10, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 23, 2013

    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