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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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IDx-DR - 00860005195619

No Description
Digital Diagnostics Inc.
V2
In Commercial Distribution

  • 00860005195619 ()


  • Retinal image analysis software

Sonic - 05711583038209

EXPRESSFIT PRO 2020.1
Sonic Innovations, Inc.
214708
In Commercial Distribution

  • 05711583038209 ()


  • Audiometric/hearing device software

Sonic - 05711583033488

EXPRESSFIT PRO 2019.1
Sonic Innovations, Inc.
196004
In Commercial Distribution

  • 05711583033488 ()


  • Audiometric/hearing device software

SIS System - 00860001580907

Version 6.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Version 7.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.
Surgical Information Sciences Inc.
6.X.X, 7.X.X
In Commercial Distribution

  • 00860001580907 ()


  • Stereotactic system application software

Sonic - 05711583030135

EXPRESSFIT PRO 2017.2
Sonic Innovations, Inc.
185295
In Commercial Distribution

  • 05711583030135 ()


  • Audiometric/hearing device software

EyeArt - 00860000470001

No Description
Eyenuk, Inc.
2.1.0
In Commercial Distribution

  • 00860000470001 ()


  • Retinal image analysis software

GN ReSound - 05708296099986

USB,AUDIGY 2.2
Gn Hearing A/S
20811722
In Commercial Distribution

  • 05708296099986 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099955

SW,FSW,RS SMART FIT 1.1#3
Gn Hearing A/S
20890700
In Commercial Distribution

  • 05708296099955 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099948

SW,FSW,AUDIGY 2.1#1
Gn Hearing A/S
20884300
In Commercial Distribution

  • 05708296099948 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099924

SW,FSW,RS SMART FIT 1.2#1
Gn Hearing A/S
20884100
In Commercial Distribution

  • 05708296099924 ()


  • Audiometric/hearing device software
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