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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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Beltone - 05708296085552

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

  • 05708296085552 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085538

DVD,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20523011
In Commercial Distribution

  • 05708296085538 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085514

DVD,FSW,RS SMART FIT 1.1,VA
Gn Hearing A/S
20522111
In Commercial Distribution

  • 05708296085514 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085507

USB,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521611
In Commercial Distribution

  • 05708296085507 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085491

DVD,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521111
In Commercial Distribution

  • 05708296085491 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085484

SW,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20521400
In Commercial Distribution

  • 05708296085484 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085422

SW,FSW,RS SMART FIT 1.3
Gn Hearing A/S
20660100
In Commercial Distribution

  • 05708296085422 ()


  • Audiometric/hearing device software

GN ReSound - 05708296089482

USB,FSW,AUDIGY 2.0
Gn Hearing A/S
20624620
In Commercial Distribution

  • 05708296089482 ()


  • Audiometric/hearing device software

GN ReSound - 05708296089475

DVD,FSW,AUDIGY 2.0
Gn Hearing A/S
20474220
In Commercial Distribution

  • 05708296089475 ()


  • Audiometric/hearing device software

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

Nile HCP - 00850031821026

A digital epilepsy care management web portal for HCP.
Ai Nile Inc
Nile for HCPs
In Commercial Distribution

  • 00850031821026 ()


  • Medication reminder application software

Nile - 00850031821019

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

  • 00850031821019 ()


  • Medication reminder application software

Nile - 00850031821002

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

  • 00850031821002 ()


  • Medication reminder application 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

FetaLink - 00850017753129

No Description
Cerner Corporation
FetaLink 200
In Commercial Distribution

  • 00850017753129 ()
10000085

  • Obstetrical monitoring/analysis software

FetaLink+ - 00850017753112

No Description
Cerner Corporation
FL+7
In Commercial Distribution

  • 00850017753112 ()


  • Obstetrical monitoring/analysis software

Oracle Health Patient Observer - 00850017753037

No Description
Cerner Corporation
CPO-SP7
In Commercial Distribution

  • 00850017753037 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Lexie Hearing - 00850022464263

iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software

Lexie Hearing - 00850022464256

Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software

Oracle Health Patient Observer - 00853023006241

No Description
Cerner Corporation
CPO-I415
In Commercial Distribution

  • 00853023006241 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Health Patient Observer - 00853023006234

No Description
Cerner Corporation
CPO-SP6
In Commercial Distribution

  • 00853023006234 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Cerner FetaLink - 00853023006227

No Description
Cerner Corporation
FetaLink200
Not in Commercial Distribution

  • 00853023006227 ()


  • Obstetrical monitoring/analysis software

FetaLink+ - 00853023006210

No Description
Cerner Corporation
FetaLink+6
In Commercial Distribution

  • 00853023006210 ()


  • Obstetrical monitoring/analysis software

Oracle Health Patient Observer - 00853023006203

No Description
Cerner Corporation
CPO-SP4
In Commercial Distribution

  • 00853023006203 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

Oracle Patient Observer - 00853023006197

No Description
Cerner Corporation
CPO-SP
In Commercial Distribution

  • 00853023006197 ()
CFG_PATOBSRVR

  • Inpatient motion surveillance software

FetaLink+ - 00853023006166

No Description
Cerner Corporation
FetaLink+5
In Commercial Distribution

  • 00853023006166 ()


  • Obstetrical monitoring/analysis software

FetaLink+® - 00853023006142

No Description
Cerner Corporation
FetaLink+4
In Commercial Distribution

  • 00853023006142 ()


  • Obstetrical monitoring/analysis software

FetaLink® - 00853023006081

No Description
Cerner Corporation
FetaLink2013
Not in Commercial Distribution

  • 00853023006081 ()


  • Obstetrical monitoring/analysis software

FetaLink+® - 00853023006050

No Description
Cerner Corporation
FetaLink+3
In Commercial Distribution

  • 00853023006050 ()


  • Obstetrical monitoring/analysis software

FetaLink® - 00853023006043

No Description
Cerner Corporation
FetaLink2014
Not in Commercial Distribution

  • 00853023006043 ()


  • Obstetrical monitoring/analysis 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

Oticon - 05707131345783

GENIE 2 2019.1 OTICON
Oticon A/S
196703
In Commercial Distribution

  • 05707131345783 ()


  • Audiometric/hearing device software

Oticon - 05707131343949

AMPLIFON GENIE 2, 2018.2 AMPLIFON
Oticon A/S
193881
In Commercial Distribution

  • 05707131343949 ()


  • Audiometric/hearing device software

Oticon - 05707131339362

GENIE 2 2018.2 OTICON
Oticon A/S
190057
In Commercial Distribution

  • 05707131339362 ()


  • Audiometric/hearing device software

Oticon - 05707131339355

AUDIGYFIT 2 2018.2 AGX HEARING
Oticon A/S
190064
In Commercial Distribution

  • 05707131339355 ()


  • Audiometric/hearing device software

Oticon - 05707131339348

PRESCRIPTIVES 2 2018.2 AVADA
Oticon A/S
190062
In Commercial Distribution

  • 05707131339348 ()


  • Audiometric/hearing device software

Oticon - 05707131339324

GENIE 2 2018.2 AUDIKA
Oticon A/S
190059
In Commercial Distribution

  • 05707131339324 ()


  • Audiometric/hearing device software
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