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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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EarliPoint - 00860009993709

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

KIDScore D3 - 05712714675317

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

Veris Health - 00860009591004

Medical Device Data Systems (MDDS)
Veris Health Inc.
Veris Health Platform
In Commercial Distribution

  • 00860009591004 ()


  • Self-care monitoring/reporting software

OculoMotor Technologies - 00860012940608

Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software

Oticon - 05707131357847

GENIE 2 2019.2 AGX HEARING
Oticon A/S
204675
In Commercial Distribution

  • 05707131357847 ()


  • Audiometric/hearing device software

Oticon - 05707131357809

GENIE 2 2019.2 VA
Oticon A/S
204671
In Commercial Distribution

  • 05707131357809 ()


  • Audiometric/hearing device software

Oticon - 05707131357793

GENIE 2 2019.2 OTICON
Oticon A/S
204670
In Commercial Distribution

  • 05707131357793 ()


  • Audiometric/hearing device software

Oticon - 05707131345837

AUDIGYFIT 2 2019.1 AGX HEARING
Oticon A/S
196708
In Commercial Distribution

  • 05707131345837 ()


  • Audiometric/hearing device software

Oticon - 05707131345820

PRESCRIPTIVES 2 2019.1 AVADA
Oticon A/S
196707
In Commercial Distribution

  • 05707131345820 ()


  • Audiometric/hearing device software

Oticon - 05707131345790

GENIE 2 2019.1 OTICON VA
Oticon A/S
196704
In Commercial Distribution

  • 05707131345790 ()


  • Audiometric/hearing device software
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