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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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GN Hearing - 05708296279616

USB,FSW AG2.15,AG1,US,UP2
Gn Hearing A/S
22748800
In Commercial Distribution

  • 05708296279616 ()


  • Audiometric/hearing device software

Beltone - 05708296279579

USB,FSW SM1.15,SP1,US,UP2
Gn Hearing A/S
22748400
In Commercial Distribution

  • 05708296279579 ()


  • Audiometric/hearing device software

Beltone - 05708296279562

SW,FSW SOLUS MAX 1.15,UP2
Gn Hearing A/S
22748300
In Commercial Distribution

  • 05708296279562 ()


  • Audiometric/hearing device software

GN ReSound - 05708296279555

USB,FSW SF1.15,AV3,US,UP2
Gn Hearing A/S
22748200
In Commercial Distribution

  • 05708296279555 ()


  • Audiometric/hearing device software

hearX - 00858177007465

Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software

hearX - 00858177007458

IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software

Hearing Help Express - 00858177007335

Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software

hiHealth Innovations - 00858177007144

Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software

Hearing Help Express - 00858177007113

iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software

hi Health Innovations - 00858177007069

IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software

GN ReSound - 05708296261000

DVD,FSW SF1.16,AV3,VA
Gn Hearing A/S
22231100
In Commercial Distribution

  • 05708296261000 ()


  • Audiometric/hearing device software

GN Hearing - 05708296260973

USB,FSW XB1.16,US
Gn Hearing A/S
22227900
In Commercial Distribution

  • 05708296260973 ()


  • Audiometric/hearing device software

GN Hearing - 05708296260942

USB,FSW AG2.16,AG1,US
Gn Hearing A/S
22227600
In Commercial Distribution

  • 05708296260942 ()


  • Audiometric/hearing device software

Beltone - 05708296260928

USB,FSW SM1.16,SP1,US
Gn Hearing A/S
22227400
In Commercial Distribution

  • 05708296260928 ()


  • Audiometric/hearing device software

GN ReSound - 05708296260904

USB,FSW SF1.16,AV3,US
Gn Hearing A/S
22227200
In Commercial Distribution

  • 05708296260904 ()


  • Audiometric/hearing device software

GN ReSound - 05708296260874

SW,FSW CS SMART FIT 1.16
Gn Hearing A/S
22226900
In Commercial Distribution

  • 05708296260874 ()


  • Audiometric/hearing device software

GN Hearing - 05708296260867

SW,FSW XE BEMORE 1.16
Gn Hearing A/S
22226800
In Commercial Distribution

  • 05708296260867 ()


  • Audiometric/hearing device software

GN Hearing - 05708296260829

SW,FSW AUDIGY 2.16
Gn Hearing A/S
22226400
In Commercial Distribution

  • 05708296260829 ()


  • Audiometric/hearing device software

Beltone - 05708296260812

SW,FSW SOLUS MAX 1.16
Gn Hearing A/S
22226300
In Commercial Distribution

  • 05708296260812 ()


  • Audiometric/hearing device software

GN ReSound - 05708296260805

SW,FSW SMART FIT 1.16
Gn Hearing A/S
22226200
In Commercial Distribution

  • 05708296260805 ()


  • Audiometric/hearing device software

GN Hearing - 05708296251391

SW,FSW,XE BEMORE 1.13,UP1
Gn Hearing A/S
22179600
In Commercial Distribution

  • 05708296251391 ()


  • Audiometric/hearing device software

GN Hearing - 05708296239153

USB,FSW XB1.14,US
Gn Hearing A/S
22224100
In Commercial Distribution

  • 05708296239153 ()


  • Audiometric/hearing device software

Beltone - 05708296239139

USB,FSW SM1.14,SP1,US
Gn Hearing A/S
22223600
In Commercial Distribution

  • 05708296239139 ()


  • Audiometric/hearing device software

GN ReSound - 05708296239115

USB,FSW SF1.14,AV3,US
Gn Hearing A/S
22223400
In Commercial Distribution

  • 05708296239115 ()


  • Audiometric/hearing device software

GN Hearing - 05708296239078

USB,FSW AG2.14,AG1,US
Gn Hearing A/S
22223800
In Commercial Distribution

  • 05708296239078 ()


  • Audiometric/hearing device software

GN Hearing - 05708296239054

SW,FSW XE BEMORE 1.14
Gn Hearing A/S
22223000
In Commercial Distribution

  • 05708296239054 ()


  • Audiometric/hearing device software

Beltone - 05708296239047

SW,FSW SOLUS MAX 1.14
Gn Hearing A/S
22222500
In Commercial Distribution

  • 05708296239047 ()


  • Audiometric/hearing device software

GN ReSound - 05708296239023

SW,FSW SMART FIT 1.14
Gn Hearing A/S
22222400
In Commercial Distribution

  • 05708296239023 ()


  • Audiometric/hearing device software

GN ReSound - 05708296238996

SW,FSW CS SMART FIT 1.14
Gn Hearing A/S
22223100
In Commercial Distribution

  • 05708296238996 ()


  • Audiometric/hearing device software

GN Hearing - 05708296238989

SW,FSW AUDIGY 2.14
Gn Hearing A/S
22222600
In Commercial Distribution

  • 05708296238989 ()


  • Audiometric/hearing device software

GN ReSound - 05708296238958

DVD,FSW SF1.14,AV3,VA
Gn Hearing A/S
22224400
In Commercial Distribution

  • 05708296238958 ()


  • Audiometric/hearing device software

GN ReSound - 05708296238552

SW,FSW,CS SMART FIT 1.12 UP#3
Gn Hearing A/S
22290800
In Commercial Distribution

  • 05708296238552 ()


  • Audiometric/hearing device software

GN Hearing - 05708296238514

USB,XEBM1.12,US,#2
Gn Hearing A/S
22170900
In Commercial Distribution

  • 05708296238514 ()


  • Audiometric/hearing device software

GN Hearing - 05708296238491

USB,XE BM1.12,UP#2
Gn Hearing A/S
22170700
In Commercial Distribution

  • 05708296238491 ()


  • Audiometric/hearing device software

GN Hearing - 05708296238460

USB,AGX2.12,US,#2
Gn Hearing A/S
22170400
In Commercial Distribution

  • 05708296238460 ()


  • Audiometric/hearing device software

GN Hearing - 05708296238453

USB,AGX2.12,UP#2
Gn Hearing A/S
22170300
In Commercial Distribution

  • 05708296238453 ()


  • Audiometric/hearing device software

Beltone - 05708296238446

USB,SM1.12,US,UP#2
Gn Hearing A/S
22170200
In Commercial Distribution

  • 05708296238446 ()


  • Audiometric/hearing device software

Beltone - 05708296238439

USB,SM1.12,UP#2
Gn Hearing A/S
22170100
In Commercial Distribution

  • 05708296238439 ()


  • Audiometric/hearing device software

GN ReSound - 05708296235483

DVD,FSW,SMART FIT 1.15,VA
Gn Hearing A/S
22222000
In Commercial Distribution

  • 05708296235483 ()


  • Audiometric/hearing device software

GN Hearing - 05708296233830

SW,FSW,XE BEMORE 1.12,UP#1
Gn Hearing A/S
22098900
In Commercial Distribution

  • 05708296233830 ()


  • Audiometric/hearing device software
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