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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 - 05714464060375

OTICON GENIE 2 2022.2 VA
Sbo Hearing A/S
247229
In Commercial Distribution

  • 05714464060375 ()


  • Audiometric/hearing device software

Audigy - 05714464060337

AUDIGYFIT 2 2022.2
Sbo Hearing A/S
247225
In Commercial Distribution

  • 05714464060337 ()


  • Audiometric/hearing device software

Philips - 05714464059843

PHILIPS HEARSUITE 2022.2
Sbo Hearing A/S
246118
In Commercial Distribution

  • 05714464059843 ()


  • Audiometric/hearing device software

Sonic - 05714464059836

SONIC EXPRESSFITPRO 2022.2
Sbo Hearing A/S
246117
In Commercial Distribution

  • 05714464059836 ()


  • Audiometric/hearing device software

Neutral - 05714464059829

OASISNXT CUSTOM 2022.2
Sbo Hearing A/S
246116
In Commercial Distribution

  • 05714464059829 ()


  • Audiometric/hearing device software

Bernafon - 05714464059812

BERNAFON OASISNXT 2022.2
Sbo Hearing A/S
246115
In Commercial Distribution

  • 05714464059812 ()


  • 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

BrainInsight - 00860000606189

No Description
Hyperfine Operations, Inc.
Version 1.0
In Commercial Distribution

  • 00860000606189 ()


  • Image segmentation application software

EyeArt - 00860000470001

No Description
Eyenuk, Inc.
2.1.0
In Commercial Distribution

  • 00860000470001 ()


  • Retinal image analysis software

Sonic - 05711583038209

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

  • 05711583038209 ()


  • Audiometric/hearing device software
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