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

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    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·October 13, 2023

    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code FPA·October 11, 2023

    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·December 10, 2018

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code OCC·October 10, 2019

    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·October 14, 2022

    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·August 7, 2024

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code OCC·April 30, 2025

    NxTAG Respiratory Pathogen Panel, REF: I051C0447

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics Inc·Product code OCC·September 5, 2024

    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics·Product code OCC·July 16, 2019

    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·June 1, 2022

    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OCC·January 30, 2023

    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    OEC Elite Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023