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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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DTX Studio™ Core - 07332747197136

DTX Studio Core 3.13 for Windows 64-bit
Nobel Biocare AB
3.13
In Commercial Distribution

  • 07332747197136 ()
300547

  • Radiology picture archiving and communication system digital archive device

DTX Studio™ Core - 07332747197129

DTX Studio Core 3.12 for Windows 64-bit
Nobel Biocare AB
3.12
In Commercial Distribution

  • 07332747197129 ()
300547

  • Radiology picture archiving and communication system digital archive device

DTX Studio™ Core - 07332747187090

DTX Studio Core 3.11 for Windows 64-bit
Nobel Biocare AB
3.11
In Commercial Distribution

  • 07332747187090 ()
300547

  • Radiology picture archiving and communication system digital archive device

DTX Studio™ Core - 07332747185102

DTX Studio Core 3.10 for Windows 64-bit
Nobel Biocare AB
3.10
In Commercial Distribution

  • 07332747185102 ()
300547

  • Radiology picture archiving and communication system digital archive device

DTX Studio™ Core - 07332747180817

DTX Studio Core 3.9 for Windows 64-bit
Nobel Biocare AB
3.9
In Commercial Distribution

  • 07332747180817 ()
300547

  • Radiology picture archiving and communication system digital archive device

DTX Studio™ Core - 07332747172874

DTX Studio Core 3.8 for Windows 64-bit
Nobel Biocare AB
3.8
In Commercial Distribution

  • 07332747172874 ()
300547

  • Radiology picture archiving and communication system digital archive device

DTX Studio™ Core - 07332747166651

DTX Studio Core 3.7 for Windows 64-bit
Nobel Biocare AB
3.7
In Commercial Distribution

  • 07332747166651 ()
300547

  • Radiology picture archiving and communication system digital archive device

OmniFlow Therapy System - 00858703006276

Software and sensor designed to provide visual feedback to respiratory patients.
ACCELERATED CARE PLUS CORP
100FLO
In Commercial Distribution

  • 00858703006276 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

Kinetigram - 00860007286506

Kinetigram is a cloud-based software platform that provides upper mobility assessment
Bioniks
v2
In Commercial Distribution

  • 00860007286506 ()
200-00201-DO-01

  • Biomechanical function analysis/rehabilitation software

Vasc Pro Table - 00718175007334

Table, Vascular Ultrasound, Vasc Pro, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
058-733
Not in Commercial Distribution

  • 00718175007334 ()
058-733

  • Multi-purpose diagnostic imaging table
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