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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 - 05714464013081

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

  • 05714464013081 ()


  • Audiometric/hearing device software

Audigy - 05714464013043

AudigyFit 2 2021.2
Sbo Hearing A/S
228223
In Commercial Distribution

  • 05714464013043 ()


  • Audiometric/hearing device software

Bernafon - 05714464013036

Bernafon OasisNxt 2021.2
Sbo Hearing A/S
228221
In Commercial Distribution

  • 05714464013036 ()


  • Audiometric/hearing device software

Neutral - 05714464013029

OasisNxt Custom 2021.2
Sbo Hearing A/S
228220
In Commercial Distribution

  • 05714464013029 ()


  • Audiometric/hearing device software

Sonic - 05714464013012

Sonic ExpressfitPro 2021.2
Sbo Hearing A/S
228219
In Commercial Distribution

  • 05714464013012 ()


  • Audiometric/hearing device software

Philips - 05714464013005

Philips HearSuite 2021.2
Sbo Hearing A/S
228218
In Commercial Distribution

  • 05714464013005 ()


  • Audiometric/hearing device software

Oticon - 05714464005901

OTICON GENIE 2 2020.2 VA
Sbo Hearing A/S
218088
In Commercial Distribution

  • 05714464005901 ()


  • Audiometric/hearing device software

Audigy - 05714464005895

AUDIGYFIT 2 2020.2
Sbo Hearing A/S
218087
In Commercial Distribution

  • 05714464005895 ()


  • Audiometric/hearing device software

Oticon - 05714464005840

OTICON GENIE 2 2020.2
Sbo Hearing A/S
218082
In Commercial Distribution

  • 05714464005840 ()


  • Audiometric/hearing device software

Philips - 05714464004560

PHILIPS HEARSUITE 2020.2
Sbo Hearing A/S
215180
In Commercial Distribution

  • 05714464004560 ()


  • Audiometric/hearing device software

Sonic - 05714464004553

SONIC EXPRESSFITPRO 2020.2
Sbo Hearing A/S
215179
In Commercial Distribution

  • 05714464004553 ()


  • Audiometric/hearing device software

Bernafon - 05714464004546

OASISNXT CUSTOM 2020.2
Sbo Hearing A/S
215178
In Commercial Distribution

  • 05714464004546 ()


  • Audiometric/hearing device software

Bernafon - 05714464004539

BERNAFON OASISNXT 2020.2
Sbo Hearing A/S
215177
In Commercial Distribution

  • 05714464004539 ()


  • Audiometric/hearing device software

Bernafon - 05714464004522

OASISNXT CUSTOM 2020.2 COSTCO
Sbo Hearing A/S
215176
In Commercial Distribution

  • 05714464004522 ()


  • Audiometric/hearing device software

Philips - 05714464003600

PHILIPS HEARSUITE 2020.1
Sbo Hearing A/S
214709
In Commercial Distribution

  • 05714464003600 ()


  • Audiometric/hearing device software

Philips - 05714464002849

HEARSUITE 2019.2
Sbo Hearing A/S
204550
In Commercial Distribution

  • 05714464002849 ()


  • Audiometric/hearing device software

Philips - 05714464000029

HEARSUITE 2019.1
Sbo Hearing A/S
196006
In Commercial Distribution

  • 05714464000029 ()


  • 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

AGXO - 05714464097036

AudigyFit 2 2023.1
Sbo Hearing A/S
255010
In Commercial Distribution

  • 05714464097036 ()


  • Audiometric/hearing device software

Oticon - 05714464097029

Oticon Genie 2 2023.1
Sbo Hearing A/S
255009
In Commercial Distribution

  • 05714464097029 ()


  • Audiometric/hearing device software

Oticon - 05714464097005

Oticon Genie 2 2023.1 VA
Sbo Hearing A/S
255007
In Commercial Distribution

  • 05714464097005 ()


  • Audiometric/hearing device software

Philips - 05714464095667

Philips HearSuite 2023.1 TRO
Sbo Hearing A/S
253223
In Commercial Distribution

  • 05714464095667 ()


  • Audiometric/hearing device software

Bernafon - 05714464095650

Bernafon Oasisnxt 2023.1
Sbo Hearing A/S
253222
In Commercial Distribution

  • 05714464095650 ()


  • Audiometric/hearing device software

Neutral - 05714464095643

Oasisnxt Custom 2023.1
Sbo Hearing A/S
253221
In Commercial Distribution

  • 05714464095643 ()


  • Audiometric/hearing device software

Sonic - 05714464095636

Sonic ExpressfitPro 2023.1
Sbo Hearing A/S
253220
In Commercial Distribution

  • 05714464095636 ()


  • Audiometric/hearing device software

Philips - 05714464095629

Philips HearSuite 2023.1
Sbo Hearing A/S
253219
In Commercial Distribution

  • 05714464095629 ()


  • Audiometric/hearing device software

Oticon - 05714464060399

OTICON GENIE 2 2022.2
Sbo Hearing A/S
247231
In Commercial Distribution

  • 05714464060399 ()


  • Audiometric/hearing device software

Oticon - 05714464060382

OTICON GENIE 2 2022.2 NHS
Sbo Hearing A/S
247230
In Commercial Distribution

  • 05714464060382 ()


  • Audiometric/hearing device software

Oticon - 05714464060375

OTICON GENIE 2 2022.2 VA
Sbo Hearing A/S
247229
In Commercial Distribution

  • 05714464060375 ()


  • Audiometric/hearing device software

Audigy - 05714464060337

AUDIGYFIT 2 2022.2
Sbo Hearing A/S
247225
In Commercial Distribution

  • 05714464060337 ()


  • Audiometric/hearing device software

Philips - 05714464059843

PHILIPS HEARSUITE 2022.2
Sbo Hearing A/S
246118
In Commercial Distribution

  • 05714464059843 ()


  • Audiometric/hearing device software

Sonic - 05714464059836

SONIC EXPRESSFITPRO 2022.2
Sbo Hearing A/S
246117
In Commercial Distribution

  • 05714464059836 ()


  • Audiometric/hearing device software

Neutral - 05714464059829

OASISNXT CUSTOM 2022.2
Sbo Hearing A/S
246116
In Commercial Distribution

  • 05714464059829 ()


  • Audiometric/hearing device software

Bernafon - 05714464059812

BERNAFON OASISNXT 2022.2
Sbo Hearing A/S
246115
In Commercial Distribution

  • 05714464059812 ()


  • Audiometric/hearing device software

Audigy - 05714464042449

AudigyFit 2 2022.1.0
Sbo Hearing A/S
236745
In Commercial Distribution

  • 05714464042449 ()


  • Audiometric/hearing device software

Oticon - 05714464042401

Oticon Genie 2 2022.1.0 VA
Sbo Hearing A/S
236741
In Commercial Distribution

  • 05714464042401 ()


  • Audiometric/hearing device software

Oticon - 05714464042388

Oticon Genie 2 2022.1.0
Sbo Hearing A/S
236739
In Commercial Distribution

  • 05714464042388 ()


  • Audiometric/hearing device software

Philips - 05714464034710

Philips HearSuite 2022.1.0
Sbo Hearing A/S
234038
In Commercial Distribution

  • 05714464034710 ()


  • Audiometric/hearing device software

Sonic - 05714464034703

Sonic ExpressfitPro 2022.1.0
Sbo Hearing A/S
234037
In Commercial Distribution

  • 05714464034703 ()


  • Audiometric/hearing device software

Neutral - 05714464034697

Oasisnxt Custom 2022.1.0
Sbo Hearing A/S
234036
In Commercial Distribution

  • 05714464034697 ()


  • Audiometric/hearing device software

Bernafon - 05714464034680

Bernafon Oasisnxt 2022.1.0
Sbo Hearing A/S
234035
In Commercial Distribution

  • 05714464034680 ()


  • 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
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