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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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JiveX - 04260632470015

Version 5.1 includes all minor versions and patch levels of 5.1
VISUS Health IT GmbH
5.1
Not in Commercial Distribution

  • 04260632470015 ()


  • Radiological PACS software

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

neotivCare - 04262390860015

The overall intended use of neotivCare is to provide an app-based objective measurement of cognition to quantify cognitive impairment. The software is intended for use by patients at the indication of medical professionals to quantify and monitor a suspected or self-reported cognitive impairment. The app is not intended as a standalone diagnostic assessment and is only indicated as a tool to support the diagnostic process of a medical professional.
neotiv GmbH
1.0.0
In Commercial Distribution

  • 04262390860015 ()


  • Cognitive assessment software

Volpara Scorecard - 09421904268333

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.5
In Commercial Distribution

  • 09421904268333 ()


  • Radiological PACS software

Volpara Density Map - 09421904268319

Volpara Density Map 4.0
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution

  • 09421904268319 ()


  • Radiological PACS software

Volpara Density Map - 09421904268289

Volpara Density Map 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268289 ()


  • Radiological PACS software

VolparaDensity - 09421904268258

VolparaDensity 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268258 ()


  • Radiological PACS software

VolparaDensity - 09421904268241

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution

  • 09421904268241 ()


  • Radiological PACS software

Visage Ease Pro - 04251332920047

No Description
Visage Imaging GmbH
2.2
In Commercial Distribution

  • 04251332920047 ()


  • Radiological PACS software

Visage Ease Pro - 04251332920030

No Description
Visage Imaging GmbH
2.0
In Commercial Distribution

  • 04251332920030 ()


  • Radiological PACS software
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