BEUDAMED
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    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 1 ·Portable Medical Technology Limited·On the market

    VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

    Device
    EU MDR · Eu Md Class 1 ·patientMpower·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 1 ·Webdoctor Limited·On the market

    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

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    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