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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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NASOMETER SOFTWARE
PENTAX OF AMERICA, INC.
6500
In Commercial Distribution

  • 04961333247301 ()


  • Speech assistive training device
VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
TPS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615029 ()
XMSGP030A09.07-001

  • Stereotactic system application software
TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software
Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
51529
In Commercial Distribution

  • 09008738515293 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
50898
Not in Commercial Distribution

  • 09008738508981 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40291
In Commercial Distribution

  • 09008737402914 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40290
In Commercial Distribution

  • 09008737402907 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38064
In Commercial Distribution

  • 09008737380649 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38062
In Commercial Distribution

  • 09008737380625 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
98330
In Commercial Distribution

  • 09008737983307 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
53106
In Commercial Distribution

  • 09008737531065 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52585
In Commercial Distribution

  • 09008737525859 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52581
In Commercial Distribution

  • 09008737525811 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52503
In Commercial Distribution

  • 09008737525033 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
42172
In Commercial Distribution

  • 09008737421724 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38063
In Commercial Distribution

  • 09008737380632 ()


  • Audiometric/hearing device software
Imaging software
GENDEX CORP.
3
In Commercial Distribution

  • EKAV101037680 ()
VIXWINPL

  • Radiology information system application software
+ QBL Software
STRYKER CORPORATION
0894000005
In Commercial Distribution

  • 07613327622799 ()
0894-000-005

  • Electronic surgical sponge-counter
QBL Software
STRYKER CORPORATION
0894000002
In Commercial Distribution

  • 07613327622775 ()
0894-000-002

  • Blood weighing scale
AI Software
STRYKER CORPORATION
0894000001
In Commercial Distribution

  • 07613327622768 ()
0894-000-001

  • Blood loss estimation application software
Planning Software
Stryker Leibinger GmbH & Co. KG
8000-021-005
In Commercial Distribution

  • 07613327513950 ()
8000-021-005

  • Stereotactic system application software
ENT Software
Stryker Leibinger GmbH & Co. KG
8000-021-001
In Commercial Distribution

  • 07613327513943 ()
8000-021-001

  • Stereotactic system application software
Software Upgrade
LIGHTLAB IMAGING, INC.
Software Upgrade
In Commercial Distribution

  • 00812059021925 ()
E4-STD-WW

  • Coronary optical coherence tomography system
Software Upgrade
LIGHTLAB IMAGING, INC.
Metallic Stent Optimization Software
In Commercial Distribution

  • 00812059021918 ()
E4-FULL-WW

  • Coronary optical coherence tomography system
68679 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 15099169676739 ()
  • 65099169686795 ()
  • 05099169706033 ()


  • Diagnostic spirometer, professional
68675 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 05099169706088 ()
  • 15099169676784 ()
  • 65099169686757 ()
  • 15099169676791 ()
  • 05099169706095 ()
  • 05099169706118 ()
  • 15099169676814 ()


  • Diagnostic spirometer, professional
68674 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 15099169676760 ()
  • 65099169686740 ()
  • 05099169706064 ()
  • 15099169676814 ()
  • 05099169706118 ()
  • 15099169676777 ()
  • 05099169706071 ()
  • 05099169706057 ()
  • 15099169676753 ()
  • 05099169706040 ()
  • 05099169706026 ()
  • 15099169676746 ()
  • 05099169706125 ()
  • 15099169676821 ()
  • 15099169676722 ()
  • 15099169676852 ()
  • 15099169676715 ()
  • 05099169706156 ()
  • 05099169706019 ()
  • 05099169706194 ()
  • 15099169676890 ()


  • Diagnostic spirometer, professional
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