BEUDAMED
    66 results · 28ms · Sources: EU EUDAMED, US FDA

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    cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971307·

    I_OPEN 0.4T

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·April 5, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    CARTO¿ 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 4, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 26, 2013

    INSPIRE 6F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

    RESERVOIR INSPIRE 8

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

    INSPIRE HARD VENOUS RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016

    INSPIRE HVR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 5, 2019

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code DTZ·October 5, 2016

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code DTZ·November 4, 2016

    INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 6, 2016

    INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALI SRL·Product code DTZ·October 20, 2016