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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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AGXO - 05714464146130

AUDIGYFIT 2 2025.1
Sbo Hearing A/S
274898
In Commercial Distribution

  • 05714464146130 ()


  • Audiometric/hearing device software

Bernafon - 05714464139422

OASISNXT CUSTOM 2024.2
Sbo Hearing A/S
270488
In Commercial Distribution

  • 05714464139422 ()


  • Audiometric/hearing device software

Bernafon - 05714464139415

BERNAFON OASISNXT 2024.2
Sbo Hearing A/S
270487
In Commercial Distribution

  • 05714464139415 ()


  • Audiometric/hearing device software

Philips - 05714464139408

PHILIPS HEARSUITE 2024.2 TRO
Sbo Hearing A/S
270486
In Commercial Distribution

  • 05714464139408 ()


  • Audiometric/hearing device software

Philips - 05714464139392

PHILIPS HEARSUITE 2024.2
Sbo Hearing A/S
270485
In Commercial Distribution

  • 05714464139392 ()


  • Audiometric/hearing device software

Sonic - 05714464139385

SONIC EXPRESSFITPRO 2024.2
Sbo Hearing A/S
270484
In Commercial Distribution

  • 05714464139385 ()


  • Audiometric/hearing device software

Oticon - 05714464139378

OTICON GENIE 2 2024.2 VA
Sbo Hearing A/S
270483
In Commercial Distribution

  • 05714464139378 ()


  • Audiometric/hearing device software

Oticon - 05714464139354

OTICON GENIE 2 2024.2
Sbo Hearing A/S
270481
In Commercial Distribution

  • 05714464139354 ()


  • Audiometric/hearing device software

Oticon - 05714464139316

AUDIGYFIT 2 2024.2
Sbo Hearing A/S
270477
In Commercial Distribution

  • 05714464139316 ()


  • Audiometric/hearing device software

Sonic - 05714464133864

SONIC EXPRESSFITPRO 2024.1
Sbo Hearing A/S
269332
In Commercial Distribution

  • 05714464133864 ()


  • Audiometric/hearing device software

Philips - 05714464131938

PHILIPS HEARSUITE 2024.1 TRO
Sbo Hearing A/S
268338
In Commercial Distribution

  • 05714464131938 ()


  • Audiometric/hearing device software

Neutral - 05714464131921

OASISNXT CUSTOM 2024.1
Sbo Hearing A/S
268337
In Commercial Distribution

  • 05714464131921 ()


  • Audiometric/hearing device software

Bernafon - 05714464131914

BERNAFON OASISNXT 2024.1
Sbo Hearing A/S
268336
In Commercial Distribution

  • 05714464131914 ()


  • Audiometric/hearing device software

Philips - 05714464131907

PHILIPS HEARSUITE 2024.1
Sbo Hearing A/S
268335
In Commercial Distribution

  • 05714464131907 ()


  • Audiometric/hearing device software

Oticon - 05714464131891

AUDIGYFIT 2 2024.1
Sbo Hearing A/S
268334
In Commercial Distribution

  • 05714464131891 ()


  • Audiometric/hearing device software

Oticon - 05714464131860

OTICON GENIE 2 2024.1 VA
Sbo Hearing A/S
268331
In Commercial Distribution

  • 05714464131860 ()


  • Audiometric/hearing device software

Oticon - 05714464131846

OTICON GENIE 2 2024.1
Sbo Hearing A/S
268329
In Commercial Distribution

  • 05714464131846 ()


  • Audiometric/hearing device software

Oticon - 05714464122615

AUDIGYFIT 2 2023.2
Sbo Hearing A/S
262883
In Commercial Distribution

  • 05714464122615 ()


  • Audiometric/hearing device software

Oticon - 05714464122561

OTICON GENIE 2 2023.2 VA
Sbo Hearing A/S
262878
In Commercial Distribution

  • 05714464122561 ()


  • Audiometric/hearing device software

Oticon - 05714464122554

OTICON GENIE 2 2023.2
Sbo Hearing A/S
262877
In Commercial Distribution

  • 05714464122554 ()


  • Audiometric/hearing device software
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