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

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    uMR 570

    FDA 510(k)
    FDA Class 2 ·Radiology

    Origin 125º Short Neck Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215024024·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197194983·Ferreira Style Breast Retractor 180x25...

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 19, 2018

    FOX PLUS PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASCENSION ANKLE FUSION NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 5, 2019

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2022

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 22, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013

    INTELECT MOBILE COMBO

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 23, 2017

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 11, 2019

    Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

    FDA Enforcement
    Class II ·Terminated·Advanced Bionics, LLC·April 10, 2019

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020