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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Classification: Class I × Clear all

    Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024

    Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024

    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024

    Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024

    Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·November 10, 2021