BEUDAMED
    723 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Regulation: Us FDA × Clear all

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger Medical, Inc.·November 20, 2024

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger Medical, Inc.·November 20, 2024

    Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·April 9, 2025

    (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 3, 2024

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·April 9, 2025

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·April 9, 2025

    Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·April 9, 2025

    Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·April 9, 2025

    Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.

    FDA Enforcement
    Class I ·Terminated·Medtronic Vascular·June 23, 2021

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 3, 2024

    A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc.·February 19, 2020

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·October 8, 2025

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·October 8, 2025

    Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc.·February 19, 2020

    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical Systems, Inc.·June 13, 2018

    Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications

    FDA Enforcement
    Class I ·Terminated·Draeger Medical Systems, Inc.·June 13, 2018

    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

    FDA Enforcement
    Class I ·Terminated·Abbott Vascular·February 26, 2020

    NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

    FDA Enforcement
    Class I ·Terminated·Abbott Vascular·February 26, 2020