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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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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

Audigy - 05714464042449

AudigyFit 2 2022.1.0
Sbo Hearing A/S
236745
In Commercial Distribution

  • 05714464042449 ()


  • Audiometric/hearing device software

Oticon - 05714464042401

Oticon Genie 2 2022.1.0 VA
Sbo Hearing A/S
236741
In Commercial Distribution

  • 05714464042401 ()


  • Audiometric/hearing device software

Oticon - 05714464042388

Oticon Genie 2 2022.1.0
Sbo Hearing A/S
236739
In Commercial Distribution

  • 05714464042388 ()


  • Audiometric/hearing device software

Philips - 05714464034710

Philips HearSuite 2022.1.0
Sbo Hearing A/S
234038
In Commercial Distribution

  • 05714464034710 ()


  • Audiometric/hearing device software

Sonic - 05714464034703

Sonic ExpressfitPro 2022.1.0
Sbo Hearing A/S
234037
In Commercial Distribution

  • 05714464034703 ()


  • Audiometric/hearing device software

Neutral - 05714464034697

Oasisnxt Custom 2022.1.0
Sbo Hearing A/S
234036
In Commercial Distribution

  • 05714464034697 ()


  • Audiometric/hearing device software

Bernafon - 05714464034680

Bernafon Oasisnxt 2022.1.0
Sbo Hearing A/S
234035
In Commercial Distribution

  • 05714464034680 ()


  • Audiometric/hearing device software

Teton Fall Detection - 05745001037000

Teton's Fall Detection system uses a device equipped with a camera to monitor the room, analyzing live video feeds through AI models that are processed locally. These models interpret human activity within the camera’s field of view and make real-time predictions, specifically detecting falls. At night, infrared lighting is used to enhance visibility, ensuring continuous monitoring. Once a fall is detected, the processed data is securely transmitted to care staff through a dedicated server, enabling timely intervention. The focus of this feature is precision and reliability, ensuring patient safety while minimizing system complexity by concentrating solely on fall detection rather than the broader ecosystem of the Teton One system.
Teton.AI ApS
R1.0
In Commercial Distribution

  • 05745001037000 ()


  • Inpatient motion surveillance software
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