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

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    Aerogen®Solo Nebulizer System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111352034·SKLARLITE XD KELLY CVD 5.5"

    DXTEND GLENOSPHERE STD D42MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE 3003895575·Product code HSD·February 6, 2017

    DXTEND RETENT PE CUP D42 +6MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE 3003895575·Product code HSD·February 6, 2017

    VITEK 2 AST ST MEROPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTERLOK BIO-MODULAR HUMERAL STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·August 25, 2011

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 18, 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