BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    Merit ONE Snare System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONE Snare Endovascular Microsnare System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Halo One Thin-Walled Guiding Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Halo One Thin-Walled Guiding Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Halo One Thin-Walled Guiding Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cordis Angiographic Needles - One-Piece Angiographic Needle with Snap-On Wing

    Device
    EU MDR · Eu Md Class 2a ·Cordis Cashel·On the market·32 countries

    Cordis Angiographic Needles - One-Piece Angiographic Needle with Snap-On Wing

    Device
    EU MDR · Eu Md Class 2a ·Cordis Cashel·On the market·32 countries

    Cordis Angiographic Needles - One-Piece Angiographic Needle with Snap-On Wing

    Device
    EU MDR · Eu Md Class 2a ·Cordis Cashel·On the market·32 countries

    Cordis Angiographic Needles - One-Piece Angiographic Needle with Snap-On Wing

    Device
    EU MDR · Eu Md Class 2a ·Cordis Cashel·On the market·32 countries

    Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical Europe Ltd·April 25, 2018

    Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·September 27, 2023

    Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items

    FDA Enforcement
    Class II ·Terminated·Natus Manufacturing Limited·January 18, 2017

    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

    ICON (LR) Limited

    Authorized representative
    🇮🇪 Ireland·37 Manufacturers·384 Devices

    Accuscience Ireland Limited

    Importer
    🇮🇪 Ireland·39 Manufacturers