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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    QEVO System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM

    PROADENO+ ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SJM REGENT HEART VALVE W/FLEX CUFF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)·Product code LWQ·November 14, 2008

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 2, 2011

    LINOX SMART TD 65/18

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

    Product Name: Allura Xper FD10C; Model number: 722001;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    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