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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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VISI-PITCH - 04961333236572

VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device

N/A - 04961333229987

Games, Software
PENTAX OF AMERICA, INC.
5167B
In Commercial Distribution

  • 04961333229987 ()


  • Electroglottograph

SONA-MATCH - 04961333229772

Sona-Match, Software
PENTAX OF AMERICA, INC.
5127
In Commercial Distribution

  • 04961333229772 ()


  • Electroglottograph

MULTI-SPEECH - 04961333229642

Multi-Speech Software
PENTAX OF AMERICA, INC.
3700
In Commercial Distribution

  • 04961333229642 ()


  • Electroglottograph

MAESTRO 11 - 09008737983307

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
98330
In Commercial Distribution

  • 09008737983307 ()


  • Audiometric/hearing device software

SYMFIT 8.0 Download - 09008737531065

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
53106
In Commercial Distribution

  • 09008737531065 ()


  • Audiometric/hearing device software

SYMFIT 8.0 USB - 09008737525859

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52585
In Commercial Distribution

  • 09008737525859 ()


  • Audiometric/hearing device software

SYMFIT 8.0 DVD - 09008737525811

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52581
In Commercial Distribution

  • 09008737525811 ()


  • Audiometric/hearing device software

SYMFIT 8.0 Download - 09008737525033

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52503
In Commercial Distribution

  • 09008737525033 ()


  • Audiometric/hearing device software

MAESTRO System Software 10 - 09008737421724

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
42172
In Commercial Distribution

  • 09008737421724 ()


  • Audiometric/hearing device software

MAESTRO 9.0 USB Package - 09008737402914

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40291
In Commercial Distribution

  • 09008737402914 ()


  • Audiometric/hearing device software

MAESTRO 8.0 USB - 09008737380649

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38064
In Commercial Distribution

  • 09008737380649 ()


  • Audiometric/hearing device software

MAESTRO 8.0 Download - 09008737380632

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38063
In Commercial Distribution

  • 09008737380632 ()


  • Audiometric/hearing device software

MAESTRO 8.0 CD - 09008737380625

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38062
In Commercial Distribution

  • 09008737380625 ()


  • Audiometric/hearing device software

MAESTRO 9.0 - 09008737370367

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37036
In Commercial Distribution

  • 09008737370367 ()


  • Audiometric/hearing device software

MAESTRO 7.0 Download - 09008737368579

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36857
Not in Commercial Distribution

  • 09008737368579 ()


  • Audiometric/hearing device software

MAESTRO 8.0 - 09008737359362

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
35936
In Commercial Distribution

  • 09008737359362 ()


  • Audiometric/hearing device software

EncoreBasic - 00606959039667

EncoreBasic Software
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959039667 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959052406

EncoreBasic Software
Respironics, Inc.
2.12
In Commercial Distribution

  • 00606959052406 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959049284

EncoreBasic Software
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049284 ()
1068689

  • Medical equipment clinical data interfacing software

EncoreBasic - 00606959046962

EncoreBasic Software
Respironics, Inc.
EncoreBasic Software - 2
In Commercial Distribution

  • 00606959046962 ()
1068689

  • Medical equipment clinical data interfacing software

SYMFIT 7.0 Package - 09008738515293

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
51529
In Commercial Distribution

  • 09008738515293 ()


  • Audiometric/hearing device software

SYMFIT 5.1 Software - 09008738508981

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
50898
Not in Commercial Distribution

  • 09008738508981 ()


  • Audiometric/hearing device software

MAESTRO 9.0 Download Package - 09008737402907

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40290
In Commercial Distribution

  • 09008737402907 ()


  • Audiometric/hearing device software

MAESTRO 7.0 - 09008737353469

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
35346
Not in Commercial Distribution

  • 09008737353469 ()


  • Audiometric/hearing device software

MAESTRO 6.0 - 09008737318628

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
31862
Not in Commercial Distribution

  • 09008737318628 ()


  • Audiometric/hearing device software

Gendex VixWin™ imaging software - EKAV101037680

Imaging software
GENDEX CORP.
3
In Commercial Distribution

  • EKAV101037680 ()
VIXWINPL

  • Radiology information system application software

Natus - 05713315008672

Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer

ICU Medical MedNet - 10887709101811

Mednet Software
ICU MEDICAL, INC.
6.32.0
In Commercial Distribution

  • 10887709101811 ()
160379203

  • Infusion pump medication-dosage application software

Cadi - 10667147001559

Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001559 ()
CADI

  • Radiology information system application software

CRW® - 10381780252658

ATLASPLAN Software
INTEGRA LIFESCIENCES CORPORATION
ATLASSW
Not in Commercial Distribution

  • M248ATLASSW1 ()
  • 10381780252658 ()


  • Neurological stereotactic surgery system

SurgiCount - 07613327622799

+ QBL Software
STRYKER CORPORATION
0894000005
In Commercial Distribution

  • 07613327622799 ()
0894-000-005

  • Electronic surgical sponge-counter

Triton - 07613327622775

QBL Software
STRYKER CORPORATION
0894000002
In Commercial Distribution

  • 07613327622775 ()
0894-000-002

  • Blood weighing scale

Triton - 07613327622768

AI Software
STRYKER CORPORATION
0894000001
In Commercial Distribution

  • 07613327622768 ()
0894-000-001

  • Blood loss estimation application software

Spirotrac - 65099169686801

68680 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

  • 05099169706101 ()
  • 15099169676807 ()
  • 65099169686801 ()


  • Diagnostic spirometer, professional

Spirotrac - 65099169686740

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

Spirotrac - 65099169686795

68679 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

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


  • Diagnostic spirometer, professional

Spirotrac - 65099169686757

68675 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

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


  • Diagnostic spirometer, professional

Voalte SmartSync - 00887761979031

Medical Software
HILL-ROM, INC.
4.1
In Commercial Distribution

  • 00887761979031 ()


  • Bedside information system application software

Voalte Patient Safety - 00887761979024

Medical Software
HILL-ROM, INC.
4.1
In Commercial Distribution

  • 00887761979024 ()


  • Bedside information system application software

NaviCare® Patient Safety Systems - 00887761985193

Medical Software
HILL-ROM, INC.
3.9
In Commercial Distribution

  • 00887761985193 ()


  • Bedside information system application software

Scopis - 07613327513950

Planning Software
Stryker Leibinger GmbH & Co. KG
8000-021-005
In Commercial Distribution

  • 07613327513950 ()
8000-021-005

  • Stereotactic system application software

Scopis - 07613327513943

ENT Software
Stryker Leibinger GmbH & Co. KG
8000-021-001
In Commercial Distribution

  • 07613327513943 ()
8000-021-001

  • Stereotactic system application software

OPTIS™ - 00812059021925

Software Upgrade
LIGHTLAB IMAGING, INC.
Software Upgrade
In Commercial Distribution

  • 00812059021925 ()
E4-STD-WW

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021918

Software Upgrade
LIGHTLAB IMAGING, INC.
Metallic Stent Optimization Software
In Commercial Distribution

  • 00812059021918 ()
E4-FULL-WW

  • Coronary optical coherence tomography system

NaviCare® WatchChild® Systems - 00887761001572

Medical Software
HILL-ROM, INC.
1.6
In Commercial Distribution

  • 00887761001572 ()


  • Obstetrics information system application software

NaviCare® SmartSync Systems - 00887761001565

Medical Software
HILL-ROM, INC.
3.6
In Commercial Distribution

  • 00887761001565 ()


  • Bedside information system application software

NaviCare® Patient Safety Systems - 00887761001558

Medical Software
HILL-ROM, INC.
3.6
In Commercial Distribution

  • 00887761001558 ()


  • Bedside information system application software

Voalte SmartSync - 00887761995093

Medical Software
HILL-ROM, INC.
4.0
In Commercial Distribution

  • 00887761995093 ()


  • Bedside information system application software

Voalte Patient Safety - 00887761995086

Medical Software
HILL-ROM, INC.
4.0
In Commercial Distribution

  • 00887761995086 ()


  • Bedside information system application software
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