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

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    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CHH·November 10, 2021

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

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

    Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code OAR·June 3, 2024

    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

    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

    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

    StabiliT TOUCH Syringe, REF: IN8VCF/B

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OAR·August 19, 2024

    Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023