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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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Nexstim NBS software - 06430063200002

NBS main software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200002 ()


  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
  • Stereotactic neuronavigation/planning system

QLAB Advanced Quantification Software - 00884838103603

Software Revision 15.5
Philips Ultrasound LLC
989606720441
In Commercial Distribution

  • 00884838103603 ()


  • Radiological PACS software

IntelliVue XDS Software - 00884838092099

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

  • 00884838092099 ()
867019

  • Bedside information system application software

IntelliVue XDS Software - 00884838123175

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

  • 00884838123175 ()
867019

  • Bedside information system application software

Affinti 70 Diaagnostic Ultrasound System Circular Edition - 00884838114258

Software Version 10.0.2
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838114258 ()


  • General-purpose ultrasound imaging system

Affinti 50 Diaagnostic Ultrasound System Circular Edition - 00884838114241

Software Version 10.0.2
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838114241 ()


  • General-purpose ultrasound imaging system

EPIQ 5W Diagnostic Ultrasound System - 00884838114128

Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system

EPIQ 5 Diagnostic Ultrasound System - 00884838114111

Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114111 ()


  • General-purpose ultrasound imaging system

IntelliVue XDS Software - 00884838109957

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

  • 00884838109957 ()
867019

  • Bedside information system application software

Nexstim NBT software - 06430063200156

NBT main software
Nexstim Oyj
2
In Commercial Distribution

  • 06430063200156 ()


  • Stereotactic neuronavigation/planning system

NexSpeech main software - 06430063200026

NexSpeech Main Software
Nexstim Oyj
2
In Commercial Distribution

  • 06430063200026 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph

BodyGuardian Connect - 00852132007293

Transmission software application
PREVENTICE TECHNOLOGIES, INC.
SW1002
In Commercial Distribution

  • 00852132007293 ()


  • Cardiopulmonary physiological parameter analysis software

AlignRT Plus - 05056190500177

AlignRT 6.0 software
VISION RT LIMITED
AlignRT 6.0
Not in Commercial Distribution

  • 05056190500177 ()


  • Radiological video camera patient positioning/tracking system

REMI Robotic Navigation System - 00850026574364

Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software

AlignRT Plus - 05056190500818

AlignRT 6.2 software
VISION RT LIMITED
AlignRT 6.2
Not in Commercial Distribution

  • 05056190500818 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500689

AlignRT 6.3 software
VISION RT LIMITED
AlignRT 6.3
In Commercial Distribution

  • 05056190500689 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500320

AlignRT 6.1 software
VISION RT LIMITED
AlignRT 6.1
Not in Commercial Distribution

  • 05056190500320 ()


  • Radiological video camera patient positioning/tracking system

SPRINT - 00850022775291

Clinical Programmer Software
SPR THERAPEUTICS, INC.
50009
In Commercial Distribution

  • 00850022775291 ()
50009

  • Analgesic PENS system

SureSmile Advanced Software - 00856379007108

SureSmile Advanced Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007108 ()
DIGI-500159

  • CAD/CAM software

SureSmile Ortho Software - 00856379007092

SureSmile Ortho Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007092 ()
DIGI-500153

  • CAD/CAM software
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