BEUDAMED
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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

    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

    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

    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

    Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator

    FDA Enforcement
    Class II ·Ongoing·Canadian Hospital Specialties Ltd.·July 24, 2024

    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system

    FDA Enforcement
    Class II ·Terminated·Epocal Inc·July 25, 2012

    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Imaging Group·August 29, 2012