BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    Locking Bolt Ø6 x 110mm

    Device
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·On the market·1 country

    Locking Bolt Ø6 x 110mm

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·OrthoXel DAC·1 device

    Med-Di-Dia Limited

    Authorized representative
    🇮🇪 Ireland·2 Manufacturers·1 Device

    TrinityBiotech

    Authorized representative
    🇮🇪 Ireland·2 Manufacturers

    Natus Manufacturing Ltd

    Authorized representative
    🇮🇪 Ireland·4 Manufacturers

    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

    Natus Manufacturing Ltd

    Importer
    🇮🇪 Ireland·4 Manufacturers

    D P Medical Systems (Ireland) Limited

    Importer
    🇮🇪 Ireland·6 Manufacturers

    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

    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·September 27, 2017

    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·September 27, 2017

    Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

    FDA Enforcement
    Class II ·Ongoing·Medtronic Vascular Galway DBA Medtronic Ireland·October 23, 2019

    Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Vascular Galway DBA Medtronic Ireland·October 23, 2019

    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

    FDA Enforcement
    Class I ·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·June 3, 2020

    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

    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

    CS Life Sciences Europe Ltd

    Authorized representative
    🇮🇪 Ireland·35 Manufacturers·444 Devices

    ICON (LR) Limited

    Authorized representative
    🇮🇪 Ireland·37 Manufacturers·384 Devices