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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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Ponto - 05712149026807

Genie Medical BAHS 2021.2 USB. ISO file for this software is 5712149026876
Oticon Medical AB
226479
In Commercial Distribution

  • 05712149026807 ()
226479

  • Audiometric/hearing device software

Sonic - 05711583038209

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

  • 05711583038209 ()


  • Audiometric/hearing device software

Sonic - 05711583037479

EXPRESSFIT PRO 2019.2
Sonic Innovations, Inc.
204549
In Commercial Distribution

  • 05711583037479 ()


  • 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 - 05711583033488

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

  • 05711583033488 ()


  • Audiometric/hearing device software

Sonic - 05711583031903

EXPRESSFIT PRO 2018.2
Sonic Innovations, Inc.
190061
In Commercial Distribution

  • 05711583031903 ()


  • Audiometric/hearing device software

Sonic - 05711583030135

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

  • 05711583030135 ()


  • Audiometric/hearing device software

Sonic - 05711583030005

EXPRESSFIT PRO 2017.1
Sonic Innovations, Inc.
181784
In Commercial Distribution

  • 05711583030005 ()


  • Audiometric/hearing device software

GN Hearing - 05708296351367

SW,FSW CS SMART FIT 1.18,UP1
Gn Hearing A/S
23351300
In Commercial Distribution

  • 05708296351367 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327409

USB,FSW XB2.0,US
Gn Hearing A/S
23118700
In Commercial Distribution

  • 05708296327409 ()


  • Audiometric/hearing device software
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