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

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    OxyMinder

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Omnilux CLEAR

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

    CHINA NAILS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    LCS TEX PCR TIB PLAT STD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 27, 2008

    TC3 RP TIBIAL INSERT S3, 15.0

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·August 12, 2011

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·July 9, 2013

    BD PHOENIX¿ YEAST ID

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JXB·June 26, 2025

    BD PHOENIX¿ YEAST ID

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JXB·June 26, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019