BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    REVEL Spacers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Origin Broach

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039707·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111809090·Kratos Broach S-Type, Size 9

    ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000

    FDA 510(k)
    FDA Class 2 ·Immunology

    REPROCESSED COMPRESSION SLEEVES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·July 1, 2011

    INTELECT ADVANCED 2CH COLOR COMBO W/EMG

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

    UNKNOWN HIP ACETABULAR LINERS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 13, 2019

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 13, 2019

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    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