BEUDAMED
    8 results · 24ms · Sources: EU EUDAMED, US FDA

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    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NYLON THREADED NEEDLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Hospira Primary Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    530G INSULIN PUMP MMT-751LNAS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·January 31, 2018

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 11, 2014

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 10, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·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