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

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    ENDOBRUSH(TM) DEVICE; OMNIBRUSH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756734233·ORTHO SPORTS BASIC UPPER PK-LF

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019315060434·

    TOTAL BILIRUBIN REAGENT, CONCENTRATED

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STERILE LAPAROTOMY SPONGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·July 21, 2025

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·September 29, 2025

    VISTA BASIC - IFVB

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·June 13, 2014

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 11, 2010

    DIGITAL RADIOGRAPHY CXDI-50G WIRELESS

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 31, 2012

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·September 19, 2025

    Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·January 20, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021