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

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    The Evolve System with the Transform Applicator

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

    K231485

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·October 25, 2025

    PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Maxxi Flow Sensor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MENTOR SMOOTH ROUND HIGH PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·April 20, 2018

    SM HPS DV 460CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·April 20, 2018

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 18, 2008

    MBT CEM KEEL TIB TRAY SZ3

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code NJL·September 1, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·July 17, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    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