BEUDAMED
    49 results · 20ms · 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 Status: Ongoing ×

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 26, 2025

    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·June 24, 2026

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·March 11, 2026

    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 27, 2025

    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 6, 2025

    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiopulmonary Ag·June 4, 2025

    human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

    FDA Enforcement
    Class II ·Ongoing·HUMAN MED AG·March 12, 2025

    Ventilator HAMILTON-C6, PN: 160021

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·June 26, 2024

    Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

    FDA Enforcement
    Class II ·Ongoing·Hamilton Medical AG·April 18, 2018

    Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

    FDA Enforcement
    Class II ·Ongoing·Hamilton Medical AG·April 18, 2018

    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    HAMILTON-C6 Intensive Care Ventilator, REF: 160021

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 31, 2022

    Hamilton-C6

    FDA Enforcement
    Class II ·Ongoing·Hamilton Medical AG·November 30, 2022

    IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

    FDA Enforcement
    Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

    HAMILTON-C6, REF: 160021

    FDA Enforcement
    Class II ·Ongoing·Hamilton Medical AG·May 3, 2023

    impression coping, repositionable, short, screw-retained, PF 4.0

    FDA Enforcement
    Class II ·Ongoing·Thommen Medical AG·March 27, 2024