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

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    Unity Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PF4 Enhanced assay

    FDA 510(k)
    FDA Class 2 ·Hematology

    IMPLANT STUDIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 9, 2020

    LIGASURE ATLAS HANDSWITCHING 20CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·September 2, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    GYNECARE TVT RETROBPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 22, 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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023