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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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IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software - R
In Commercial Distribution

  • 00884838123175 ()
867019

  • Bedside information system application software
Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system
Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114111 ()


  • General-purpose ultrasound imaging system
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838092099 ()
867019

  • Bedside information system application software
PCH100 STANDALONE SOFTWARE
WELCH ALLYN, INC.
901052
In Commercial Distribution

  • 00732094128482 ()
704525

  • Electrocardiograph, professional, multichannel
NBT main software
Nexstim Oyj
2
In Commercial Distribution

  • 06430063200156 ()


  • Stereotactic neuronavigation/planning system
NexSpeech Analyzer Software
Nexstim Oyj
2
In Commercial Distribution

  • 06430063200033 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
NexSpeech Main Software
Nexstim Oyj
2
In Commercial Distribution

  • 06430063200026 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
NBS main software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200002 ()


  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
  • Stereotactic neuronavigation/planning system
Clinical Programmer Software
SPR THERAPEUTICS, INC.
50009
In Commercial Distribution

  • 00850022775291 ()
50009

  • Analgesic PENS system
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