BEUDAMED
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    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    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

    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Ireland, Inc.·December 31, 2025

    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

    Apo B Reagent, REF: OSR6143

    FDA Enforcement
    Class III ·Ongoing·Beckman Coulter Ireland, Inc.·June 4, 2025

    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

    FDA Enforcement
    Class III ·Ongoing·T.G. Eakin Limited·October 2, 2024

    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·July 31, 2024

    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

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

    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

    Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·March 27, 2019

    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·March 27, 2019

    Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·March 27, 2019