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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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DVD,FSW,AUDIGY 1.0
Gn Hearing A/S
20474200
In Commercial Distribution

  • 05708296078745 ()


  • Audiometric/hearing device software
USB,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473500
In Commercial Distribution

  • 05708296078462 ()


  • Audiometric/hearing device software
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
The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.
Earlitec Diagnostics, Inc.
EPT001
In Commercial Distribution

  • 00860009993709 ()


  • Neurodevelopmental disorder interpretive software
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Vitrolife A/S
16531
In Commercial Distribution

  • 05712714675317 ()
16531

  • Assisted reproduction embryo-assessment software
Medical Device Data Systems (MDDS)
Veris Health Inc.
Veris Health Platform
In Commercial Distribution

  • 00860009591004 ()


  • Self-care monitoring/reporting software
Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software
GENIE 2 2019.2 AGX HEARING
Oticon A/S
204675
In Commercial Distribution

  • 05707131357847 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 VA
Oticon A/S
204671
In Commercial Distribution

  • 05707131357809 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 OTICON
Oticon A/S
204670
In Commercial Distribution

  • 05707131357793 ()


  • Audiometric/hearing device software
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