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Sources: EU EUDAMED, US FDA
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The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 28, 2022
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
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
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
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items
FDA Enforcement
Class II
·Terminated·Natus Manufacturing Limited·January 18, 2017
ICON (LR) Limited
Authorized representative
🇮🇪 Ireland·37 Manufacturers·384 Devices
Atlantico Systems, Ltd.
Authorized representative
🇮🇪 Ireland·10 Manufacturers·165 Devices
Siemens Healthcare Diagnostics Manufacturing Limited
Authorized representative
🇮🇪 Ireland·6 Manufacturers
Becton Dickinson Ireland Limited
Authorized representative
🇮🇪 Ireland·21 Manufacturers
E C REP LIMITED
Authorized representative
🇮🇪 Ireland·15 Manufacturers·1499 Devices
AMO Ireland
Authorized representative
🇮🇪 Ireland·4 Manufacturers
Eurolink Europe Compliance Limited
Authorized representative
🇮🇪 Ireland·35 Manufacturers·252 Devices
Renew Health Ltd.
Authorized representative
🇮🇪 Ireland·2 Manufacturers
DePuy Ireland UC
Authorized representative
🇮🇪 Ireland·8 Manufacturers
Cost Saving Solutions Europe Ltd
Authorized representative
🇮🇪 Ireland·2 Manufacturers
Stryker European Operations Limited
Authorized representative
🇮🇪 Ireland·16 Manufacturers
ClotPlus Limited
Authorized representative
🇮🇪 Ireland·3 Manufacturers
Merit Medical Ireland Ltd
Authorized representative
🇮🇪 Ireland·3 Manufacturers
Meridius Medical Europe Limited
Authorized representative
🇮🇪 Ireland·36 Manufacturers·720 Devices
Teleflex Medical
Authorized representative
🇮🇪 Ireland·10 Manufacturers