BEUDAMED
    125 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Country: Ireland × Clear all

    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    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

    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

    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

    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