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

  • 00850016231383 ()


  • Audiometric/hearing device software
No Description
Cerner Corporation
FL+Android1
In Commercial Distribution

  • 00850017753136 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FetaLink 200
In Commercial Distribution

  • 00850017753129 ()
10000085

  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FL+7
In Commercial Distribution

  • 00850017753112 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
CPO-SP7
In Commercial Distribution

  • 00850017753037 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
No Description
Cerner Corporation
CPO-I415
In Commercial Distribution

  • 00853023006241 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software
No Description
Cerner Corporation
CPO-SP6
In Commercial Distribution

  • 00853023006234 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software
No Description
Cerner Corporation
FetaLink200
Not in Commercial Distribution

  • 00853023006227 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FetaLink+6
In Commercial Distribution

  • 00853023006210 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
CPO-SP4
In Commercial Distribution

  • 00853023006203 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software
No Description
Cerner Corporation
CPO-SP
In Commercial Distribution

  • 00853023006197 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software
No Description
Cerner Corporation
FetaLink+5
In Commercial Distribution

  • 00853023006166 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FetaLink+4
In Commercial Distribution

  • 00853023006142 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FetaLink2013
Not in Commercial Distribution

  • 00853023006081 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FetaLink+3
In Commercial Distribution

  • 00853023006050 ()


  • Obstetrical monitoring/analysis software
No Description
Cerner Corporation
FetaLink2014
Not in Commercial Distribution

  • 00853023006043 ()


  • Obstetrical monitoring/analysis 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
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