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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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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

Sonic - 05714464122547

SONIC EXPRESSFITPRO 2023.2
Sbo Hearing A/S
262876
In Commercial Distribution

  • 05714464122547 ()


  • Audiometric/hearing device software

Philips - 05714464122530

PHILIPS HEARSUITE 2023.2 TRO
Sbo Hearing A/S
262875
In Commercial Distribution

  • 05714464122530 ()


  • Audiometric/hearing device software

Philips - 05714464122523

PHILIPS HEARSUITE 2023.2
Sbo Hearing A/S
262874
In Commercial Distribution

  • 05714464122523 ()


  • Audiometric/hearing device software

Bernafon - 05714464122516

BERNAFON OASISNXT 2023.2
Sbo Hearing A/S
262873
In Commercial Distribution

  • 05714464122516 ()


  • Audiometric/hearing device software

Bernafon - 05714464122509

OASISNXT CUSTOM 2023.2
Sbo Hearing A/S
262872
In Commercial Distribution

  • 05714464122509 ()


  • Audiometric/hearing device software

Bernafon - 05714464146246

OASISNXT CUSTOM 2025.1
Sbo Hearing A/S
274909
In Commercial Distribution

  • 05714464146246 ()


  • Audiometric/hearing device software

Bernafon - 05714464146239

BERNAFON OASISNXT 2025.1
Sbo Hearing A/S
274908
In Commercial Distribution

  • 05714464146239 ()


  • Audiometric/hearing device software

Philips - 05714464146222

PHILIPS HEARSUITE 2025.1 TRO
Sbo Hearing A/S
274907
In Commercial Distribution

  • 05714464146222 ()


  • Audiometric/hearing device software

Philips - 05714464146215

PHILIPS HEARSUITE 2025.1
Sbo Hearing A/S
274906
In Commercial Distribution

  • 05714464146215 ()


  • Audiometric/hearing device software

Oticon - 05714464146192

OTICON GENIE 2 2025.1 VA
Sbo Hearing A/S
274904
In Commercial Distribution

  • 05714464146192 ()


  • Audiometric/hearing device software

Oticon - 05714464146178

OTICON GENIE 2 2025.1
Sbo Hearing A/S
274902
In Commercial Distribution

  • 05714464146178 ()


  • Audiometric/hearing device software

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

myBETAapp - 05713495000060

No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000053

No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000046

No Description
Phillips-Medisize A/S
Mac Thin Client (Desktop)
Not in Commercial Distribution

  • 05713495000046 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000039

No Description
Phillips-Medisize A/S
Windows Thin Client (Desktop)
Not in Commercial Distribution

  • 05713495000039 ()
84601063

  • Medication reminder application software

Oticon - 05714464013104

Oticon Genie 2 2021.2
Sbo Hearing A/S
228229
In Commercial Distribution

  • 05714464013104 ()


  • Audiometric/hearing device software

Oticon - 05714464013081

Oticon Genie 2 2021.2 VA
Sbo Hearing A/S
228227
In Commercial Distribution

  • 05714464013081 ()


  • Audiometric/hearing device software
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