BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517220899·ARM15T CoCr Rod, 110mm Conventional PB

    CLEARFIX

    FDA UDI
    Medos International Sàrl·10886705012619·CLEARFIX Meniscal Rasp Straight-Up / 45 Degrees...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113851·ARBISSER ANTERIOR CHAMBER CANNULA 30GA ANG 7MM

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197133·Revision Knee Spiral Reamer- Hudson Short Flute...

    iFuse Implant System - iFuse Navigation

    FDA 510(k)
    FDA Class 2 ·Neurology

    Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2025

    Truliant

    FDA UDI
    Exactech, Inc.·10885862556257·TRIAL, TIBIAL INSERT, CR, NEUTRAL, SIZE 1

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·December 5, 2008

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2013

    STERNALOCK 360 MULTI-IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·December 19, 2018

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011