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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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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

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

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 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 9.0 Download Package - 09008737402907

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

  • 09008737402907 ()


  • Audiometric/hearing device software

ICU Medical MedNet - 10887709101811

Mednet Software
ICU MEDICAL, INC.
6.32.0
In Commercial Distribution

  • 10887709101811 ()
160379203

  • Infusion pump medication-dosage application software

Vyaire - 04250892905945

SentrySuite Software
Jaeger Medical GmbH
3.30
In Commercial Distribution

  • 04250892905945 ()
V-770968

  • Pulmonary function analysis system, adult

Vyaire - 04250892905891

SentrySuite Software
Jaeger Medical GmbH
3.20
In Commercial Distribution

  • 04250892905891 ()
V-770965

  • Cardiopulmonary stress exercise monitoring system

Vyaire - 04250892905709

SentrySuite Software
Jaeger Medical GmbH
3.10
In Commercial Distribution

  • 04250892905709 ()
V-770962-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900667

SentrySuite Software
Jaeger Medical GmbH
2.19
Not in Commercial Distribution

  • 04250892900667 ()
V-770845-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900186

SentrySuite Software
Jaeger Medical GmbH
2.17
Not in Commercial Distribution

  • 04250892900186 ()
V-770844-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900179

SentrySuite Software
Jaeger Medical GmbH
2.15
Not in Commercial Distribution

  • 04250892900179 ()
V-770843-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900162

SentrySuite Software
Jaeger Medical GmbH
2.13
Not in Commercial Distribution

  • 04250892900162 ()
V-770842-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900100

JLAB Software
Jaeger Medical GmbH
5.7
Not in Commercial Distribution

  • 04250892900100 ()
V-770808

  • Pulmonary function analysis system, adult

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

EncoreBasic - 00606959039667

EncoreBasic Software
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959039667 ()
1068689

  • Medical equipment clinical data interfacing software

Mammotome - 00841911101833

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
SCMSW6
In Commercial Distribution

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

Mammotome - 00841911100638

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
Version 6.2
In Commercial Distribution

  • 00841911100638 ()


  • Mammographic stereotactic biopsy system

Cadi - 10667147001559

Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001559 ()
CADI

  • Radiology information system application software

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

Arial - 00840948100840

Arial Software
Securitas Healthcare LLC
54302
In Commercial Distribution

  • 00840948100840 ()


  • Alarm application software

Bionic Navigator™ 3D - 00191506007546

4.1 Software
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-7101-410
In Commercial Distribution

  • 00191506007546 ()


  • Implantable electrical stimulation device management software

CRW® - 10381780252658

ATLASPLAN Software
INTEGRA LIFESCIENCES CORPORATION
ATLASSW
Not in Commercial Distribution

  • M248ATLASSW1 ()
  • 10381780252658 ()


  • Neurological stereotactic surgery system

Spirotrac - 65099169686801

68680 software
VITALOGRAPH (IRELAND) LIMITED
7000
In Commercial Distribution

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


  • 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

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

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

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
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