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

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Horizon Medical Imaging 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 imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·June 18, 2014

    Horizon Medical Imaging It 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 imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·August 6, 2014

    McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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 imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·May 21, 2014

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Information Solutions LLC·October 9, 2013

    McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It 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 imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Imaging Group·September 28, 2016

    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 24, 2016

    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

    FDA Enforcement
    Class II ·Terminated·Visicu, Inc.·December 16, 2015

    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 8, 2017

    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.

    FDA Enforcement
    Class II ·Terminated·Hyperion Medical·August 27, 2014

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 13, 2017

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 8, 2018

    Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 18, 2015

    Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·August 17, 2016

    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

    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

    AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·March 29, 2017

    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·December 28, 2016

    Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·May 27, 2015

    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.

    FDA Enforcement
    Class II ·Terminated·Myco Medical Supplies Inc·March 6, 2013