BEUDAMED
    49 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Country: Ireland × Clear all

    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

    Alcon Clareon IOL with AutonoMe Delivery System

    FDA Enforcement
    Class II ·Terminated·Alcon Laboratories Ireland, Ltd·June 29, 2022

    Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 14, 2021

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

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

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·March 27, 2024

    ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·December 3, 2014

    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 2, 2019

    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

    FDA Enforcement
    Class II ·Terminated·Cook Ireland Ltd.·September 12, 2012

    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 28, 2021

    Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·May 22, 2019

    Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·May 22, 2019

    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

    Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.

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

    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

    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

    FDA Enforcement
    Class II ·Ongoing·Creganna Medical Devices·August 9, 2023

    Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·June 26, 2019

    RANDOX Total Bilirubin.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·December 13, 2023

    Calibration Serum Level 3 CAL2351

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·January 24, 2024

    RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

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

    IgE Calibrator Series

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·October 12, 2016