14 results
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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ICON (LR) Limited
Authorized representative
🇮🇪 Ireland·37 Manufacturers·384 Devices
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 24, 2024
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
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·September 18, 2019
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
Cordis Medical Holdings Unlimited Company
Importer
🇮🇪 Ireland·2 Manufacturers
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
FDA Enforcement
Class II
·Ongoing·Depuy Ireland UC·January 18, 2023
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical Division·November 22, 2023
Hader Solutions and Distribution LTD
Importer
🇮🇪 Ireland·1 Manufacturer
Murray Surgical Limited
Importer
🇮🇪 Ireland·1 Manufacturer
Premier Medical Ltd.
Importer
🇮🇪 Ireland·6 Manufacturers
AMO Ireland
Importer
🇮🇪 Ireland·7 Manufacturers
Hospital Services Limited
Importer
🇮🇪 Ireland·10 Manufacturers
CRITICAL HEALTHCARE LIMITED
Importer
🇮🇪 Ireland·69 Manufacturers