BEUDAMED
    96 results · 18ms · 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 Classification: Class Ii ×

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 17, 2016

    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·September 10, 2025

    VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 20, 2016

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017

    Merge RadSuite software. Radiological image processing system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 14, 2016

    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·December 7, 2016

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·May 31, 2017

    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 31, 2016

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·January 25, 2017

    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·May 10, 2017

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 20, 2016

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017

    Merge Cardio software.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017

    iConnect Enterprise Archive software.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·April 5, 2017

    Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·December 21, 2016

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·April 5, 2017

    Merge OrthoPACS software.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·June 28, 2017

    Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 28, 2016