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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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SW,FSW,BT SOLUS MAX 1.1
Gn Hearing A/S
20523900
In Commercial Distribution

  • 05708296085552 ()


  • Audiometric/hearing device software
DVD,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20523011
In Commercial Distribution

  • 05708296085538 ()


  • Audiometric/hearing device software
DVD,FSW,RS SMART FIT 1.1,VA
Gn Hearing A/S
20522111
In Commercial Distribution

  • 05708296085514 ()


  • Audiometric/hearing device software
USB,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521611
In Commercial Distribution

  • 05708296085507 ()


  • Audiometric/hearing device software
DVD,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521111
In Commercial Distribution

  • 05708296085491 ()


  • Audiometric/hearing device software
SW,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20521400
In Commercial Distribution

  • 05708296085484 ()


  • Audiometric/hearing device software
SW,FSW,RS SMART FIT 1.3
Gn Hearing A/S
20660100
In Commercial Distribution

  • 05708296085422 ()


  • Audiometric/hearing device software
USB,FSW,AUDIGY 2.0
Gn Hearing A/S
20624620
In Commercial Distribution

  • 05708296089482 ()


  • Audiometric/hearing device software
DVD,FSW,AUDIGY 2.0
Gn Hearing A/S
20474220
In Commercial Distribution

  • 05708296089475 ()


  • Audiometric/hearing device software
SW,FSW,AUDIGY 2.0
Gn Hearing A/S
20624500
In Commercial Distribution

  • 05708296089468 ()


  • Audiometric/hearing device software
SW,FSW,AUDIGY 1.1
Gn Hearing A/S
20638700
In Commercial Distribution

  • 05708296089451 ()


  • Audiometric/hearing device software
USB,FSW,BT SOLUS MAX 1.1,US
Gn Hearing A/S
20638211
In Commercial Distribution

  • 05708296089444 ()


  • Audiometric/hearing device software
DVD,FSW,BT SOLUS MAX 1.1,US
Gn Hearing A/S
20637911
In Commercial Distribution

  • 05708296089437 ()


  • Audiometric/hearing device software
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-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-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
A digital epilepsy care management web portal for HCP.
Ai Nile Inc
Nile for HCPs
In Commercial Distribution

  • 00850031821026 ()


  • Medication reminder application software
A digital epilepsy care management platform application for Android.
Ai Nile Inc
Nile for Android
In Commercial Distribution

  • 00850031821019 ()


  • Medication reminder application software
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution

  • 00850031821002 ()


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

  • 00850016231390 ()


  • Audiometric/hearing device software
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