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    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·March 4, 2020

    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·August 8, 2018

    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 18, 2021

    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·November 4, 2020

    Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·January 18, 2017

    Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

    FDA Enforcement
    Class II ·Completed·C.R. Bard, Inc.·April 26, 2017

    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 24, 2025

    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.

    FDA Enforcement
    Class II ·Ongoing·TELEFLEX LLC·November 23, 2022

    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 3, 2025

    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 20, 2016