16 results
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16ms
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Sources: EU EUDAMED, US FDA
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
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
FDA Enforcement
Class II
·Ongoing·Haag-Streit USA Inc·May 19, 2021
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
FDA Enforcement
Class II
·Terminated·AGFA Corp.·August 22, 2012
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 30, 2021
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·July 28, 2021
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
FDA Enforcement
Class II
·Terminated·AGFA Healthcare Corp.·November 25, 2015
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·October 5, 2016
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·April 20, 2016
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 2021
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
FDA Enforcement
Class II
·Terminated·Pdg Product Design Group Inc·October 1, 2014
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·November 6, 2013
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.
FDA Enforcement
Class II
·Terminated·PF Consumer Healthcare 1 LLC·June 5, 2019
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.
FDA Enforcement
Class II
·Terminated·PF Consumer Healthcare 1 LLC·June 5, 2019