BEUDAMED
    114 results · 26ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 12, 2015

    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 12, 2015

    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 12, 2015

    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

    FDA Enforcement
    Class I ·Terminated·Acist Medical Systems·March 10, 2021

    BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A

    FDA Enforcement
    Class I ·Ongoing·Merit Medical Systems, Inc.·April 1, 2026

    Inspire Model 3028, IV Implantable Pulse Generator

    FDA Enforcement
    Class I ·Ongoing·Inspire Medical Systems Inc.·July 3, 2024

    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    FDA Enforcement
    Class I ·Terminated·Merit Medical Systems, Inc.·April 5, 2017

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    FDA Enforcement
    Class I ·Terminated·Engineered Medical Systems,Inc·April 17, 2013

    Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

    FDA Enforcement
    Class I ·Terminated·Merit Medical Systems, Inc.·February 26, 2014

    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

    FDA Enforcement
    Class I ·Ongoing·Maquet Medical Systems USA·December 13, 2023

    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

    FDA Enforcement
    Class I ·Terminated·Draeger Medical Systems, Inc.·April 16, 2014

    ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical Systems, Inc.·April 9, 2014

    ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018