BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    SoundBite® Crossing System XS Peripheral

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QLAB QUANTIFICATION SOFTWARE HEART MODEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Non-contact Infrared Body Thermometer, model:HTD8823US

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 24, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

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

    WHEELCHAIR ACCESSORY

    FDA Adverse Event
    UNKNOWN·Product code INE·July 16, 2013

    Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

    FDA Enforcement
    Class III ·Ongoing·AGILENT TECHNOLOGIES INC./US·April 19, 2023

    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