BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    TENS and EMS Stimulation (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113974·HYDRO-DISSECT CANNULA 25GA ANGLED 8MM

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020393·INTRG WHISP-Z ROTH 1BIC -17T 0A 022 LO

    D-LUX

    FDA 510(k)
    FDA Class 2 ·Dental

    ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925

    FDA 510(k)
    FDA Class 1 ·Dental

    I-STAT

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 6, 2016

    AMPLATZER DUCT OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MAE·November 17, 2008

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·July 16, 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