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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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Sonic - 05711583030135

EXPRESSFIT PRO 2017.2
Sonic Innovations, Inc.
185295
In Commercial Distribution

  • 05711583030135 ()


  • Audiometric/hearing device software

Sonic - 05711583030005

EXPRESSFIT PRO 2017.1
Sonic Innovations, Inc.
181784
In Commercial Distribution

  • 05711583030005 ()


  • Audiometric/hearing device software

GN Hearing - 05708296351367

SW,FSW CS SMART FIT 1.18,UP1
Gn Hearing A/S
23351300
In Commercial Distribution

  • 05708296351367 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327409

USB,FSW XB2.0,US
Gn Hearing A/S
23118700
In Commercial Distribution

  • 05708296327409 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327386

USB,FSW SM2.0,SP1,US
Gn Hearing A/S
23118500
In Commercial Distribution

  • 05708296327386 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327362

USB,FSW SF2.0,AV3,US
Gn Hearing A/S
23118300
In Commercial Distribution

  • 05708296327362 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327324

USB,FSW AG3.0,AG1,US
Gn Hearing A/S
23117900
In Commercial Distribution

  • 05708296327324 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327300

SW,FSW XE BEMORE 2.0
Gn Hearing A/S
23117700
In Commercial Distribution

  • 05708296327300 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327294

SW,FSW SOLUS MAX 2.0
Gn Hearing A/S
23117600
In Commercial Distribution

  • 05708296327294 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327270

SW,FSW SMART FIT 2.0
Gn Hearing A/S
23117400
In Commercial Distribution

  • 05708296327270 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327232

SW,FSW CS SMART FIT 2.0
Gn Hearing A/S
23116900
In Commercial Distribution

  • 05708296327232 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327225

SW,FSW AUDIGY 3.0
Gn Hearing A/S
23116800
In Commercial Distribution

  • 05708296327225 ()


  • Audiometric/hearing device software

GN Hearing - 05708296327201

DVD,FSW SF2.0,AV3,VA
Gn Hearing A/S
23116500
In Commercial Distribution

  • 05708296327201 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319213

USB,FSW XB1.18,US
Gn Hearing A/S
22929000
In Commercial Distribution

  • 05708296319213 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319206

USB,FSW XB1.18
Gn Hearing A/S
22928900
In Commercial Distribution

  • 05708296319206 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319190

USB,FSW SM1.18,SP1,US
Gn Hearing A/S
22928800
In Commercial Distribution

  • 05708296319190 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319176

USB,FSW SF1.18,AV3,US
Gn Hearing A/S
22928600
In Commercial Distribution

  • 05708296319176 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319169

USB,FSW SF1.18,AV3
Gn Hearing A/S
22928500
In Commercial Distribution

  • 05708296319169 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319138

USB,FSW AG2.18,AG1,US
Gn Hearing A/S
22928200
In Commercial Distribution

  • 05708296319138 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319121

USB,FSW AG2.18,AG1
Gn Hearing A/S
22928100
In Commercial Distribution

  • 05708296319121 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319114

SW,FSW XE BEMORE 1.18
Gn Hearing A/S
22928000
In Commercial Distribution

  • 05708296319114 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319107

SW,FSW SOLUS MAX 1.18
Gn Hearing A/S
22927900
In Commercial Distribution

  • 05708296319107 ()


  • Audiometric/hearing device software

GN Hearing - 05708296319015

DVD,FSW SF1.18,AV3,VA
Gn Hearing A/S
22927000
In Commercial Distribution

  • 05708296319015 ()


  • Audiometric/hearing device software

GN Hearing - 05708296305476

USB,FSW XB1.17,US
Gn Hearing A/S
22853200
In Commercial Distribution

  • 05708296305476 ()


  • Audiometric/hearing device software

Beltone - 05708296305452

USB,FSW SM1.17,SP1,US
Gn Hearing A/S
22853000
In Commercial Distribution

  • 05708296305452 ()


  • Audiometric/hearing device software

GN ReSound - 05708296305438

USB,FSW SF1.17,AV3,US
Gn Hearing A/S
22852800
In Commercial Distribution

  • 05708296305438 ()


  • Audiometric/hearing device software

GN Hearing - 05708296305391

USB,FSW AG2.17,AG1,US
Gn Hearing A/S
22852400
In Commercial Distribution

  • 05708296305391 ()


  • Audiometric/hearing device software

GN Hearing - 05708296305377

SW,FSW XE BEMORE 1.17
Gn Hearing A/S
22852200
In Commercial Distribution

  • 05708296305377 ()


  • Audiometric/hearing device software

Beltone - 05708296305360

SW,FSW SOLUS MAX 1.17
Gn Hearing A/S
22852100
In Commercial Distribution

  • 05708296305360 ()


  • Audiometric/hearing device software

GN ReSound - 05708296305346

SW,FSW SMART FIT 1.17
Gn Hearing A/S
22851900
In Commercial Distribution

  • 05708296305346 ()


  • Audiometric/hearing device software

GN ReSound - 05708296305315

SW,FSW CS SMART FIT 1.17
Gn Hearing A/S
22851600
In Commercial Distribution

  • 05708296305315 ()


  • Audiometric/hearing device software

GN Hearing - 05708296305308

SW,FSW AUDIGY 2.17
Gn Hearing A/S
22851500
In Commercial Distribution

  • 05708296305308 ()


  • Audiometric/hearing device software

GN ReSound - 05708296305285

DVD,FSW SF1.17,AV3,VA
Gn Hearing A/S
22851300
In Commercial Distribution

  • 05708296305285 ()


  • Audiometric/hearing device software

GN Hearing - 05708296386222

USB,FSW XB2.1,US,UP2
Gn Hearing A/S
23723000
In Commercial Distribution

  • 05708296386222 ()


  • Audiometric/hearing device software

GN Hearing - 05708296386208

USB,FSW SM2.1,SP1,US,UP2
Gn Hearing A/S
23722800
In Commercial Distribution

  • 05708296386208 ()


  • Audiometric/hearing device software

GN Hearing - 05708296386185

USB,FSW SF2.1,AV3,US,UP2
Gn Hearing A/S
23722600
In Commercial Distribution

  • 05708296386185 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371846

USB,FSW XB2.0,US,UP3
Gn Hearing A/S
23532300
In Commercial Distribution

  • 05708296371846 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371822

USB,FSW SM2.0,SP1,US,UP3
Gn Hearing A/S
23532100
In Commercial Distribution

  • 05708296371822 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371808

USB,FSW SF2.0,AV3,US,UP3
Gn Hearing A/S
23531900
In Commercial Distribution

  • 05708296371808 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371761

USB,FSW AG3.0,AG1,US,UP3
Gn Hearing A/S
23531500
In Commercial Distribution

  • 05708296371761 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371747

SW,FSW XE BEMORE 2.0,UP3
Gn Hearing A/S
23531300
In Commercial Distribution

  • 05708296371747 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371730

SW,FSW SOLUS MAX 2.0,UP3
Gn Hearing A/S
23531200
In Commercial Distribution

  • 05708296371730 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371716

SW,FSW SMART FIT 2.0,UP3
Gn Hearing A/S
23531000
In Commercial Distribution

  • 05708296371716 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371679

SW,FSW CS SMART FIT 2.0,UP3
Gn Hearing A/S
23530600
In Commercial Distribution

  • 05708296371679 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371662

SW,FSW AUDIGY 3.0,UP3
Gn Hearing A/S
23530500
In Commercial Distribution

  • 05708296371662 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371631

DVD,FSW SF2.0,AV3,VA,UP3
Gn Hearing A/S
23530200
In Commercial Distribution

  • 05708296371631 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371549

USB,FSW XB2.0,US,UP2
Gn Hearing A/S
23386000
In Commercial Distribution

  • 05708296371549 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371525

USB,FSW SM2.0,SP1,US,UP2
Gn Hearing A/S
23385800
In Commercial Distribution

  • 05708296371525 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371501

USB,FSW SF2.0,AV3,US,UP2
Gn Hearing A/S
23385600
In Commercial Distribution

  • 05708296371501 ()


  • Audiometric/hearing device software

GN Hearing - 05708296371464

SW,FSW XE BEMORE 2.0,UP2
Gn Hearing A/S
23385200
In Commercial Distribution

  • 05708296371464 ()


  • Audiometric/hearing device software
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