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

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    DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACETABULAR PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRYSTAR, MODEL 4500M

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

    PERCLOSE PROGLIDE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·December 9, 2024

    4 FR S/L GROSHONG NXT CLEARVUE BASIC KIT W/MICROINTRODUCER

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code LJS·March 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

    SELUTE PICOTIP LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    COCR FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·November 6, 2019

    XLPE LINER ELEVATED RIM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 6, 2019

    TRILOGY SHELL

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·November 6, 2019

    STARCLOSE SE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·September 18, 2024

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·February 4, 2011

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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