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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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Oticon - 05707131328434

GENIE 2 2016.2
Oticon A/S
176611
In Commercial Distribution

  • 05707131328434 ()


  • Audiometric/hearing device software

Oticon - 05707131378774

GENIE 2, 2020.1 VA
Oticon A/S
214208
In Commercial Distribution

  • 05707131378774 ()


  • Audiometric/hearing device software

Oticon - 05707131378767

AUDIGYFIT 2, 2020.1 AGX HEARING
Oticon A/S
214207
In Commercial Distribution

  • 05707131378767 ()


  • Audiometric/hearing device software

Oticon - 05707131378712

GENIE 2, 2020.1 OTICON
Oticon A/S
214202
In Commercial Distribution

  • 05707131378712 ()


  • Audiometric/hearing device software

REMI - 00860005388158

REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software

REMI - 00860005388110

REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution

  • 00860005388110 ()


  • Bioelectrical signal analysis software

IDx-DR - 00860005195626

No Description
Digital Diagnostics Inc.
v2.3
In Commercial Distribution

  • 00860005195626 ()


  • Retinal image analysis software

IDx-DR - 00860005195619

No Description
Digital Diagnostics Inc.
V2
In Commercial Distribution

  • 00860005195619 ()


  • Retinal image analysis 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

GN Hearing - 05708296198573

SW,FSW,AUDIGY 2.7
Gn Hearing A/S
21499300
In Commercial Distribution

  • 05708296198573 ()


  • Audiometric/hearing device software
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