BEUDAMED
    47 results · 17ms · Sources: EU EUDAMED, US FDA

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    Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C

    FDA Enforcement
    Class II ·Ongoing·AMD Medicom Inc.·June 24, 2026

    Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.

    FDA Enforcement
    Class II ·Ongoing·Raz Design Inc·March 18, 2026

    IntelePACS - InteleConnect / TechPortal

    FDA Enforcement
    Class II ·Ongoing·INTELERAD MEDICAL SYSTEMS INCORPORATED·December 3, 2025

    FloPatch FP120, REF: FP120-FOT01-005

    FDA Enforcement
    Class III ·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025

    Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·July 30, 2025

    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025

    Change Healthcare Cardiology Hemodynamics Software

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 2025

    Change Healthcare Cardiology Hemo Software

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 2025

    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

    FDA Enforcement
    Class I ·Ongoing·Conavi Medical Inc.·April 30, 2025

    IntelePACS (Image Fusion Module) - InteleViewer

    FDA Enforcement
    Class II ·Ongoing·INTELERAD MEDICAL SYSTEMS INCORPORATED·March 5, 2025

    Change Healthcare Cardiology Hemodynamics software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Change Healthcare Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    McKesson Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.

    FDA Enforcement
    Class I ·Ongoing·Kinova Inc·October 23, 2024

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    FDA Enforcement
    Class II ·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024

    Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024

    Horizon Cardiology Hemo. Version 12.2.

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024

    McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024

    NxTAG Respiratory Pathogen Panel, REF: I051C0447

    FDA Enforcement
    Class II ·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024

    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

    FDA Enforcement
    Class II ·Ongoing·ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL·September 4, 2024