BEUDAMED
    22 results · 17ms · Sources: EU EUDAMED, US FDA

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    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 28, 2019

    ARIES System and ARIES M1 System

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·May 24, 2017

    ARIES HSV 1&2 Assay, Part Number/REF 50-10017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·January 26, 2022

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·February 9, 2022

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES SARS-CoV-2 Assay

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 24, 2022

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·November 2, 2022

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·December 31, 2014

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·May 22, 2013

    Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.

    FDA Enforcement
    Class II ·Terminated·SRI Surgical·September 5, 2012

    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

    FDA Enforcement
    Class II ·Terminated·Iris Diagnostics·September 2, 2015

    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·March 26, 2025

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare It·November 6, 2013