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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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Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software
AcrySof® IQ Toric IOL Calculator
Alcon Laboratories, Inc.
Version 3
In Commercial Distribution

  • 00380659909467 ()


  • Intraocular lens calculation software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X 2018.1 USB CARD
In Commercial Distribution

  • 00842318171436 ()
86212-000

  • Audiometric/hearing device software
Sandman Elite 9.3 Install CD ENU
Embla Systems Ltd
4283000
In Commercial Distribution

  • 00382830043533 ()


  • Sleep disorder interpretive software
Enterprise 5.2 Installation CD
Embla Systems Ltd
1249014
In Commercial Distribution

  • 00382830043489 ()


  • Sleep disorder interpretive software
RemLogic 3.3.2 Installation CD ENU
Embla Systems Ltd
012001
In Commercial Distribution

  • 00382830043441 ()


  • Sleep disorder interpretive software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117212 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117205 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117199 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117182 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
INSPIRE X
In Commercial Distribution

  • 00842318117175 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for Android
In Commercial Distribution

  • 00842318130846 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for iOS
In Commercial Distribution

  • 00842318130839 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for Android
In Commercial Distribution

  • 00842318130822 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for iOS
In Commercial Distribution

  • 00842318130815 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for Android
In Commercial Distribution

  • 00842318130808 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for iOS
In Commercial Distribution

  • 00842318130792 ()


  • 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
FL+7
In Commercial Distribution

  • 00850017753112 ()


  • Obstetrical monitoring/analysis software
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.
Momentum Health Inc
Momentum Spine
In Commercial Distribution

  • 00628774533007 ()


  • Posture imaging/analysis software
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software
Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
GENEA BIOMEDX PTY LTD
GERI-SCA-05
In Commercial Distribution

  • 09348265003086 ()


  • Assisted reproduction embryo-assessment software
Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
GENEA BIOMEDX PTY LTD
GERI-SCA-04
In Commercial Distribution

  • 09348265003079 ()


  • Assisted reproduction embryo-assessment software
Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables multiple users to access and review patient/embryo data, using a Chrome browser on their PC workstations.
GENEA BIOMEDX PTY LTD
GERI-GCS-01
In Commercial Distribution

  • 09348265003024 ()


  • Assisted reproduction embryo-assessment software
No Description
COCHLEAR LIMITED
2.0
In Commercial Distribution

  • 09321502063999 ()
P1877856

  • Audiometric/hearing device software
Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
downloadable
COCHLEAR LIMITED
P1487112
In Commercial Distribution

  • 09321502044943 ()
P1487112

  • Audiometric/hearing device software
Version 5.2
COCHLEAR LIMITED
P1487131
In Commercial Distribution

  • 09321502044936 ()
P1487131

  • Audiometric/hearing device software
Nucleus Smart App
COCHLEAR LIMITED
P1285539
In Commercial Distribution

  • 09321502043236 ()
P1285539

  • Audiometric/hearing device software
Custom Sound Suite 5.1 Download
COCHLEAR LIMITED
P1256009
In Commercial Distribution

  • 09321502043212 ()
P1256009

  • Audiometric/hearing device software
Custom Sound Suite 5.1 CD
COCHLEAR LIMITED
P1257243
In Commercial Distribution

  • 09321502043205 ()
P1257243

  • Audiometric/hearing device software
CD
COCHLEAR LIMITED
P772796
In Commercial Distribution

  • 09321502038829 ()
P772796

  • Audiometric/hearing device software
Download
COCHLEAR LIMITED
P772803
In Commercial Distribution

  • 09321502038812 ()
P772803

  • Audiometric/hearing device software
Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software
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