BEUDAMED
    22 results · 8ms · Sources: EU EUDAMED, US FDA

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

    Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·October 4, 2023

    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿ King LTS-D" Supraglottic Airway.

    FDA Enforcement
    Class II ·Terminated·Bound Tree Medical·July 15, 2020

    Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·November 6, 2024

    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    FDA Enforcement
    Class II ·Terminated·Besmed Health Business Corporation·October 24, 2018

    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·January 17, 2024

    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.

    FDA Enforcement
    Class II ·Terminated·Ambu Inc.·March 30, 2016

    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 18, 2020

    Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular·March 17, 2021

    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular·March 17, 2021

    AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    FDA Enforcement
    Class II ·Terminated·HF Acquisition Co. LLC·August 19, 2020

    Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·May 14, 2025

    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000

    FDA Enforcement
    Class II ·Ongoing·Ambu Inc.·July 27, 2022

    KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024

    KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430

    FDA Enforcement
    Class II ·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024