BEUDAMED
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    Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

    FDA Enforcement
    Class II ·Terminated·Natus Manufacturing Limited·March 3, 2021

    Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable

    FDA Enforcement
    Class II ·Ongoing·THERAKOS DEVELOPMENT LIMITED·April 22, 2026

    Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical Europe Ltd·April 18, 2018

    RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·November 8, 2023

    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

    FDA Enforcement
    Class II ·Ongoing·Mallinckrodt Pharmaceuticals Ireland Ltd·February 16, 2022

    RX Series Copper (Cu) Assay Ref. Number CU2340

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·February 14, 2024

    Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934

    FDA Enforcement
    Class II ·Ongoing·Signature Orthopaedics Europe Ltd·April 1, 2020

    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·November 8, 2023

    RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·November 8, 2023

    RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·November 8, 2023

    Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical Europe Ltd·April 18, 2018

    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·August 16, 2023

    IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·December 14, 2022

    IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·December 14, 2022

    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

    Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical Europe Ltd·April 18, 2018

    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 3, 2018

    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·November 8, 2023

    Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·October 26, 2016

    The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Ireland, Inc.·January 28, 2026