BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    MyPlant II Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    MIO ADVANCE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FPA·July 20, 2021

    PSL ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONGOOSE ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 15, 2020

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R

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

    MONGOOSE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 15, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

    UNKNOWN ARCOM RINGLOC LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 17, 2013

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 27, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018