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

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    SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045463·Barrel Shaver, 11mm

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045470·Barrel Sizer, 11mm

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    C.T.M. MOBILITY SCOOTER HS515(3W)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)

    FDA Adverse Event
    Injury ·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code GKZ·June 1, 2011

    IMPAX CV OUTBOUND (RESULTS MGMT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 15, 2013

    DURAN ANCORE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·March 23, 2023

    DURAN ANCORE RING

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·March 23, 2023

    PINNACLE SECTOR II CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 18, 2013

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021