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

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    Digital Ultrasonic Diagnostic Imaging System (Model: F6)

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLARLESS BI-METRIC POROUS STEM ALLIANCE X-SERIES

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·April 7, 2017

    HIGH SPEED EMG MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    JBAIDS ANTHRAX DETECTION KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    M2A-38 CUP 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 5, 2017

    M2A 38MMX54MM CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 12, 2018

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·September 1, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 17, 2013

    BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017