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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 6.0 - 09008737318628

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

  • 09008737318628 ()


  • Audiometric/hearing device 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

Mammotome - 00841911101833

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

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

Hearing Help Express - 00858177007236

Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set

QuantaFlo - 00859433006123

Software Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph

Lumipulse G ROMA - 00869164000017

Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD

TrackX - 00860099000837

TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software

Natus - 05713315008672

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

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer

On Call Diabetes Management Software - 00682607001118

PC Software
ACON LABORATORIES, INC.
1.2.89
In Commercial Distribution

  • 00682607001118 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

Diopsys® - 00850514007091

NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system

Cadi - 00066714700155

Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 00066714700155 ()
CADI

  • Radiology information system application software

Playbook - 00840194493871

Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system

DataTrak - 00886368000841

DataTrak Software
Thermogenesis Corp.
150040
In Commercial Distribution

  • 00886368000841 ()


  • Blood centrifugation system containment kit

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

Welch Allyn, Inc. - 00732094296334

TAGconnect Software
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296334 ()
TAGECG-SWF

  • Electrocardiographic ambulatory recorder
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