BEUDAMED
    11 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    MiniCap Extended Life PD Transfer Set

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·January 13, 2021

    MONARCH Bronchoscope. Model Number: MBR-000211-B

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·November 26, 2025

    American Contract Systems Biopsy Drape Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·November 12, 2025

    BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025

    American Contract Systems Special Procedure Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Gyn Laparoscopy convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 7, 2024

    BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018