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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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Sony - 05714880199420

Sony | Hearing Control App WA
Ws Audiology Usa, Inc.
Sony | Hearing Control WA
In Commercial Distribution

  • 05714880199420 ()
21026345

  • Audiometric/hearing device software

Sony - 05714880189308

Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software

CONNEXX - 05714880187229

APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution

  • 05714880187229 ()
21023158

  • Audiometric/hearing device software

Widex - 05714880213270

ACC SOUNDCONNECT LANG PACK_1
Widex A/S
ACC SOUNDCONNECT LANG PACK_1
In Commercial Distribution

  • 05714880213270 ()
8 928 0100 000

  • Audiometric/hearing device software

Genie Medical - 05712149027590

SALES PACK, GENIE MEDICAL BAHS 2024.2 USB
Oticon Medical AB
275203
In Commercial Distribution

  • 05712149027590 ()
275203

  • Audiometric/hearing device software

Ponto - 05712149025671

Genie Medical BAHS 2020.2 VA US, ISO file
Oticon Medical AB
197603
Not in Commercial Distribution

  • 05712149025671 ()
213367

  • Audiometric/hearing device software

Genie Medical - 05712149027644

FLEX LINK GENIE MEDICAL BAHS 24.2
Oticon Medical AB
275351
In Commercial Distribution

  • 05712149027644 ()
275351

  • Audiometric/hearing device software

Genie Medical - 05712149027637

ISO FILE, GENIE MEDICAL BAHS 2024.2 US VA
Oticon Medical AB
275209
In Commercial Distribution

  • 05712149027637 ()
275209

  • Audiometric/hearing device software

Ponto - 05712149027279

SALES PACK, GENIE MEDICAL BAHS 2023.1 DVD
Oticon Medical AB
254436
In Commercial Distribution

  • 05712149027279 ()
254436

  • Audiometric/hearing device software

Ponto - 05712149027262

SALES PACK, GENIE MEDICAL BAHS 2023.1 USB
Oticon Medical AB
254434
In Commercial Distribution

  • 05712149027262 ()
254434

  • Audiometric/hearing device software

Ponto - 05712149027255

ISO FILE, GENIE MEDICAL BAHS 2023.1 US VA
Oticon Medical AB
256950
In Commercial Distribution

  • 05712149027255 ()
256950

  • Audiometric/hearing device software

Ponto - 05712149026982

Genie Medical BAHS 2022.1 DVD. ISO file for this software is 5712149026999
Oticon Medical AB
235649
In Commercial Distribution

  • 05712149026982 ()
235649

  • Audiometric/hearing device software

Ponto - 05712149026975

Genie Medical BAHS 2022.1 USB. ISO file for this software is 5712149026999
Oticon Medical AB
235639
In Commercial Distribution

  • 05712149026975 ()
235639

  • Audiometric/hearing device software

Ponto - 05712149026814

Genie Medical BAHS 2021.2 DVD. ISO file for this software is 5712149026876
Oticon Medical AB
226483
In Commercial Distribution

  • 05712149026814 ()
226483

  • Audiometric/hearing device software

Ponto - 05712149026807

Genie Medical BAHS 2021.2 USB. ISO file for this software is 5712149026876
Oticon Medical AB
226479
In Commercial Distribution

  • 05712149026807 ()
226479

  • Audiometric/hearing device software

Bernafon - 05711584115862

OASIS NXT 2020.1 COSTCO
Bernafon AG
214707
In Commercial Distribution

  • 05711584115862 ()


  • Audiometric/hearing device software

Bernafon - 05711584115855

OASIS NXT 2020.1
Bernafon AG
214706
In Commercial Distribution

  • 05711584115855 ()


  • Audiometric/hearing device software

Bernafon - 05711584115848

OASIS NXT 2020.1 CUSTOM
Bernafon AG
214705
In Commercial Distribution

  • 05711584115848 ()


  • Audiometric/hearing device software

StealthConnect - 00643169705432

SFTW KIT 9735696 STEALTHCONNECT SYS
MEDTRONIC NAVIGATION, INC.
9735696
In Commercial Distribution

  • 00643169705432 ()


  • Stereotactic system application software

Clue App - 04260749840046

Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840046 ()


  • Self-care monitoring/reporting software

Clue App - 04260749840039

Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840039 ()


  • Self-care monitoring/reporting software

Clue Conceive - 04260749840022

Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840022 ()


  • Self-care monitoring/reporting software

Clue Conceive - 04260749840015

Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860203

No Description
ONCARE GmbH
1.12
In Commercial Distribution

  • 04260658860203 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860173

No Description
ONCARE GmbH
1.11
In Commercial Distribution

  • 04260658860173 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860142

No Description
ONCARE GmbH
1.10
In Commercial Distribution

  • 04260658860142 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860111

No Description
ONCARE GmbH
1.9
In Commercial Distribution

  • 04260658860111 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860081

No Description
ONCARE GmbH
1.8
In Commercial Distribution

  • 04260658860081 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860067

No Description
ONCARE GmbH
1.7
In Commercial Distribution

  • 04260658860067 ()


  • Self-care monitoring/reporting software

myoncare - 04260658860043

No Description
ONCARE GmbH
1.6.2
In Commercial Distribution

  • 04260658860043 ()


  • Self-care monitoring/reporting software

HBIdb - 04251341900054

No Description
CORSCIENCE GmbH & Co. KG
CS20401
In Commercial Distribution

  • 04251341900054 ()


  • Bioelectrical signal analysis software

CUSTOM SOUND PRO 7.0 CD - 09321502074148

No Description
Cochlear Americas Corporation
P2002452CD
In Commercial Distribution

  • 09321502074148 ()


  • Audiometric/hearing device software

OSIA FITTING SOFTWARE 2 CD - 09321502074131

No Description
Cochlear Americas Corporation
P1348428CD
In Commercial Distribution

  • 09321502074131 ()


  • Audiometric/hearing device software

Custom Sound® Pro - 09321502065948

No Description
COCHLEAR LIMITED
7.0
In Commercial Distribution

  • 09321502065948 ()
P1846133

  • Audiometric/hearing device software

Cochlear Research Platform ECochG Software - 09321502063999

No Description
COCHLEAR LIMITED
2.0
In Commercial Distribution

  • 09321502063999 ()
P1877856

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502062206

for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502062190

for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software

Custom Sound® Pro - 09321502062176

No Description
COCHLEAR LIMITED
6.3
In Commercial Distribution

  • 09321502062176 ()
P1835193

  • Audiometric/hearing device software

Cochlear - 09321502046145

Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software

Cochlear - 09321502046138

Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
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