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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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GN ReSound - 05708296089468

SW,FSW,AUDIGY 2.0
Gn Hearing A/S
20624500
In Commercial Distribution

  • 05708296089468 ()


  • Audiometric/hearing device software

GN ReSound - 05708296089451

SW,FSW,AUDIGY 1.1
Gn Hearing A/S
20638700
In Commercial Distribution

  • 05708296089451 ()


  • Audiometric/hearing device software

Beltone - 05708296089444

USB,FSW,BT SOLUS MAX 1.1,US
Gn Hearing A/S
20638211
In Commercial Distribution

  • 05708296089444 ()


  • Audiometric/hearing device software

Beltone - 05708296089437

DVD,FSW,BT SOLUS MAX 1.1,US
Gn Hearing A/S
20637911
In Commercial Distribution

  • 05708296089437 ()


  • Audiometric/hearing device software

AEYE Health - 00850035651032

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
In Commercial Distribution



  • Retinal image analysis software

AEYE Health - 00850035651018

AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
Aeye Health, Inc.
AEYE-DS-Epic
Not in Commercial Distribution

  • 00850035651018 ()


  • Retinal image analysis software

AEYE Health - 00850035651001

AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
Not in Commercial Distribution

  • 00850035651001 ()


  • Retinal image analysis software

otoTune app - 00850016231390

APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software

otoTune app - 00850016231383

APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software

FetaLink+ - 00850017753136

No Description
Cerner Corporation
FL+Android1
In Commercial Distribution

  • 00850017753136 ()


  • Obstetrical monitoring/analysis software
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