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

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
No Description
COCHLEAR LIMITED
6.3
In Commercial Distribution

  • 09321502062176 ()
P1835193

  • 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
Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software
Program Baha Sound Processors
Cochlear Bone Anchored Solutions AB
P803255
In Commercial Distribution

  • 09321502036030 ()
P803255

  • Audiometric/hearing device software
Version 4.4 CD
COCHLEAR LIMITED
P705394
In Commercial Distribution

  • 09321502033381 ()
P705394

  • Audiometric/hearing device software
Custom Sound Suite 4.4 Download
COCHLEAR LIMITED
P705392
In Commercial Distribution

  • 09321502033374 ()
P705392

  • Audiometric/hearing device software
No Description
COCHLEAR LIMITED
Z538300
In Commercial Distribution

  • 09321502032230 ()
Z538300

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 CAM
COCHLEAR LIMITED
Z532160
In Commercial Distribution

  • 09321502029612 ()
Z532160

  • Audiometric/hearing device software
CSS4.0 SERVICE PACK 1 - ENG - CAM
COCHLEAR LIMITED
Z475097
In Commercial Distribution

  • 09321502029605 ()
Z475097

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH
COCHLEAR LIMITED
Z361240
In Commercial Distribution

  • 09321502029599 ()
Z361240

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.2 SPANISH (US)
COCHLEAR LIMITED
Z301347
In Commercial Distribution

  • 09321502029568 ()
Z301347

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.2 FRENCH (US)
COCHLEAR LIMITED
Z301344
In Commercial Distribution

  • 09321502029551 ()
Z301344

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.0 DAL SR US ENGLISH
COCHLEAR LIMITED
Z252571
In Commercial Distribution

  • 09321502029537 ()
Z252571

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.1 SPANISH (US)
COCHLEAR LIMITED
Z248945
In Commercial Distribution

  • 09321502029520 ()
Z248945

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.0 SPANISH (US)
COCHLEAR LIMITED
Z239932
In Commercial Distribution

  • 09321502029513 ()
Z239932

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.0 FRENCH (US)
COCHLEAR LIMITED
Z239930
In Commercial Distribution

  • 09321502029506 ()
Z239930

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.1 SP3 (US) - CD
COCHLEAR LIMITED
Z540369
In Commercial Distribution

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 4.1 SERVICE PACK 2 ROW-CANADA
COCHLEAR LIMITED
Z532157
In Commercial Distribution

  • 09321502029445 ()
Z532157

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
No Description
COCHLEAR LIMITED
6.2
In Commercial Distribution

  • 09321502057332 ()
P1774431

  • Audiometric/hearing device software
Custom Sound Suite 6.1
COCHLEAR LIMITED
P1764756
In Commercial Distribution

  • 09321502055833 ()
P1764756

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1701584
In Commercial Distribution

  • 09321502053037 ()
P1701584

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1682914
In Commercial Distribution

  • 09321502053013 ()
P1682914

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution

  • 09321502053006 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • 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
No Description
COCHLEAR LIMITED
Z538301
In Commercial Distribution

  • 09321502032247 ()
Z538301

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.1 ENGLISH (US)
COCHLEAR LIMITED
Z248940
In Commercial Distribution

  • 09321502019873 ()
Z248940

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 2.0 SR2 US ENGLISH
COCHLEAR LIMITED
Z229456
In Commercial Distribution

  • 09321502018913 ()
Z229456

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.0 US ENGLISH
COCHLEAR LIMITED
Z220129
In Commercial Distribution

  • 09321502018906 ()
Z220129

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 2.0 SR1 FRENCH
COCHLEAR LIMITED
Z194952
In Commercial Distribution

  • 09321502011921 ()
Z194952

  • Audiometric/hearing device software
CUSTOM SND SUITE 1.3 SERV RELEASE 1
COCHLEAR LIMITED
Z61155
In Commercial Distribution

  • 09321502011624 ()
Z61155

  • Audiometric/hearing device software
CLINICAL PROGRAMMING SYSTEM
COCHLEAR LIMITED
Z43102
In Commercial Distribution

  • 09321502002448 ()
Z43102

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.2 ENGLISH (US)
COCHLEAR LIMITED
Z274923
In Commercial Distribution

  • 09321502020480 ()
Z274923

  • Audiometric/hearing device software
No Description
MeVis Medical Solutions AG
1.3.2-IT
In Commercial Distribution

  • 04260483290282 ()


  • Image segmentation application software
No Description
MeVis Medical Solutions AG
1.3
In Commercial Distribution

  • 04260483290268 ()


  • Image segmentation application software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device 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
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