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

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    Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MLKJ

    FDA UDI
    Weifang Mingliang Electronics Co., Ltd.·06974077940023·

    Biogensis Implant System-Kisses

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOBEAM NARROW BAND LIGHT THERAPY DEVICES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 12, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    VIPER2 1.45 DIA GUIDEWIRE, BLU

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code LXH·November 11, 2014

    THERMOCOOL® SF UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 23, 2013

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 20, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 15, 2013

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025