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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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Widex - 05706069858471

COMPASS GPS 3.3 package (English)
Widex A/S
COMPASS GPS
In Commercial Distribution

  • 05706069858471 ()
7 503 0135 001

  • Audiometric/hearing device software

Oticon - 05707131328939

OTICON USB GENIE 2 2016.2
Oticon A/S
177037
In Commercial Distribution

  • 05707131328939 ()


  • Audiometric/hearing device software

Oticon - 05707131328922

AVADA USB GENIE 2 2016.2
Oticon A/S
177036
In Commercial Distribution

  • 05707131328922 ()


  • Audiometric/hearing device software

Oticon - 05707131328915

AUDIGY USB GENIE 2 2016.2
Oticon A/S
177035
In Commercial Distribution

  • 05707131328915 ()


  • Audiometric/hearing device software

Oticon - 05707131328496

GENIE 2 VA 2016.2
Oticon A/S
176617
In Commercial Distribution

  • 05707131328496 ()


  • Audiometric/hearing device software

Oticon - 05707131328441

AUDIGYFIT 2 2016.2
Oticon A/S
176612
In Commercial Distribution

  • 05707131328441 ()


  • Audiometric/hearing device software

Oticon - 05707131328434

GENIE 2 2016.2
Oticon A/S
176611
In Commercial Distribution

  • 05707131328434 ()


  • Audiometric/hearing device software

Widex - 05706069543247

Compass V5.7.2 CD-ROM
Widex A/S
COMPASS
In Commercial Distribution

  • 05706069543247 ()
9 512 0044 100

  • Audiometric/hearing device software

Neuroventis Platform - 05419980275011

No Description
Neuroventis
2.x.x
In Commercial Distribution

  • 05419980275011 ()


  • Medication reminder application software

Neuroventis Platform - 05419980275004

No Description
Neuroventis
1.x.x
Not in Commercial Distribution

  • 05419980275004 ()


  • Medication reminder application software

Neuroreader - 05700002060471

No Description
Brainreader ApS
2.7
In Commercial Distribution



  • Image segmentation application software

Neuroreader - 05700002060464

No Description
Brainreader ApS
2.6
In Commercial Distribution



  • Image segmentation application software

Neuroreader - 05700002060457

No Description
Brainreader ApS
2.5
Not in Commercial Distribution



  • Image segmentation application software

Neuroreader - 05700002060440

No Description
Brainreader ApS
2.4
Not in Commercial Distribution



  • Image segmentation application software

Neuroreader - 05700002060433

No Description
Brainreader ApS
2.3
Not in Commercial Distribution



  • Image segmentation application software

Neuroreader - 05700002060419

No Description
Brainreader ApS
2.2.9
Not in Commercial Distribution



  • Image segmentation application software

Neuroreader - 05700002060402

No Description
Brainreader ApS
2.2.8
Not in Commercial Distribution

  • 05700002060402 ()


  • Image segmentation application software

Coselgi - 05706069510010

Coselgi C-Tune 2.0
Widex A/S
C-Tune
In Commercial Distribution

  • 05706069510010 ()
9 513 0102 000

  • Audiometric/hearing device software

Bernafon - 05711584115862

OASIS NXT 2020.1 COSTCO
Bernafon AG
214707
In Commercial Distribution

  • 05711584115862 ()


  • Audiometric/hearing device software

Bernafon - 05711584115855

OASIS NXT 2020.1
Bernafon AG
214706
In Commercial Distribution

  • 05711584115855 ()


  • Audiometric/hearing device software

Bernafon - 05711584115848

OASIS NXT 2020.1 CUSTOM
Bernafon AG
214705
In Commercial Distribution

  • 05711584115848 ()


  • Audiometric/hearing device software

Bernafon - 05711584106563

OASIS NXT 2019.2 CUSTOM
Bernafon AG
204542
In Commercial Distribution

  • 05711584106563 ()


  • Audiometric/hearing device software

Bernafon - 05711584106556

OASIS NXT 2019.2
Bernafon AG
204541
In Commercial Distribution

  • 05711584106556 ()


  • Audiometric/hearing device software

Bernafon - 05711584106549

OASIS NXT 2019.2 COSTCO
Bernafon AG
204540
In Commercial Distribution

  • 05711584106549 ()


  • Audiometric/hearing device software

Bernafon - 05711584094082

OASIS NXT 2019.1 COSTCO
Bernafon AG
196003
In Commercial Distribution

  • 05711584094082 ()


  • Audiometric/hearing device software

Bernafon - 05711584094075

OASIS NXT 2019.1
Bernafon AG
196002
In Commercial Distribution

  • 05711584094075 ()


  • Audiometric/hearing device software

Bernafon - 05711584094068

OASIS NXT 2019.1 CUSTOM
Bernafon AG
196001
In Commercial Distribution

  • 05711584094068 ()


  • Audiometric/hearing device software

Bernafon - 05711584086353

OASIS NXT 2018.2 COSTCO
Bernafon AG
190054
In Commercial Distribution

  • 05711584086353 ()


  • Audiometric/hearing device software

Bernafon - 05711584085363

OASIS NXT 2018.2
Bernafon AG
190056
In Commercial Distribution

  • 05711584085363 ()


  • Audiometric/hearing device software

Bernafon - 05711584085356

OASIS NXT 2018.2 CUSTOM
Bernafon AG
190055
In Commercial Distribution

  • 05711584085356 ()


  • Audiometric/hearing device software

Bernafon - 05711584083215

OASIS NXT 2017.2 COSTCO
Bernafon AG
186358
In Commercial Distribution

  • 05711584083215 ()


  • Audiometric/hearing device software

Bernafon - 05711584082867

OASIS NXT 2017.1.1
Bernafon AG
185336
In Commercial Distribution

  • 05711584082867 ()


  • Audiometric/hearing device software

Bernafon - 05711584082850

HEARTOO STUDIO
Bernafon AG
185294
In Commercial Distribution

  • 05711584082850 ()


  • Audiometric/hearing device software

Bernafon - 05711584082843

OASIS 26.0 CUTOM
Bernafon AG
185293
In Commercial Distribution

  • 05711584082843 ()


  • Audiometric/hearing device software

Bernafon - 05711584082836

OASIS 26.0
Bernafon AG
185292
In Commercial Distribution

  • 05711584082836 ()


  • Audiometric/hearing device software

Bernafon - 05711584082829

OASIS NXT 2017.2 CUSTOM
Bernafon AG
185291
In Commercial Distribution

  • 05711584082829 ()


  • Audiometric/hearing device software

Bernafon - 05711584082812

OASIS NXT 2017.2
Bernafon AG
185290
In Commercial Distribution

  • 05711584082812 ()


  • Audiometric/hearing device software

Bernafon - 05711584075999

OASIS NXT 2017.1 CUSTOM
Bernafon AG
181794
In Commercial Distribution

  • 05711584075999 ()


  • Audiometric/hearing device software

Bernafon - 05711584075975

OASIS 25.0 CUSTOM
Bernafon AG
181792
In Commercial Distribution

  • 05711584075975 ()


  • Audiometric/hearing device software

GN ReSound - 05708296140695

DVD,FSW,RS AVENTA 3.10,VA
Gn Hearing A/S
20326901
In Commercial Distribution

  • 05708296140695 ()


  • Audiometric/hearing device software

GN ReSound - 05708296140688

DVD,FSW,RS AVENTA 3.10,US
Gn Hearing A/S
20327101
In Commercial Distribution

  • 05708296140688 ()


  • Audiometric/hearing device software

GN ReSound - 05708296140145

USB,FSW,RS AVENTA 3.10,US
Gn Hearing A/S
20316301
In Commercial Distribution

  • 05708296140145 ()


  • Audiometric/hearing device software

Beltone - 05708296140138

SW,FSW,BT SOLUS MAX 1.0
Gn Hearing A/S
20318700
In Commercial Distribution

  • 05708296140138 ()


  • Audiometric/hearing device software

GN ReSound - 05708296140121

SW,FSW,RS SMART FIT 1.0
Gn Hearing A/S
20318600
In Commercial Distribution

  • 05708296140121 ()


  • Audiometric/hearing device software

GN ReSound - 05708296140084

SW,FSW,RS AVENTA 3.10
Gn Hearing A/S
20316201
In Commercial Distribution

  • 05708296140084 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099986

USB,AUDIGY 2.2
Gn Hearing A/S
20811722
In Commercial Distribution

  • 05708296099986 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099955

SW,FSW,RS SMART FIT 1.1#3
Gn Hearing A/S
20890700
In Commercial Distribution

  • 05708296099955 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099948

SW,FSW,AUDIGY 2.1#1
Gn Hearing A/S
20884300
In Commercial Distribution

  • 05708296099948 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099924

SW,FSW,RS SMART FIT 1.2#1
Gn Hearing A/S
20884100
In Commercial Distribution

  • 05708296099924 ()


  • Audiometric/hearing device software

GN ReSound - 05708296099917

SW,FSW,COSTCO AVENTA 3.13
Gn Hearing A/S
20878900
In Commercial Distribution

  • 05708296099917 ()


  • Audiometric/hearing device software
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