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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DVD,FSW,RS AVENTA 3.10,VA
Gn Hearing A/S
20326901
In Commercial Distribution

  • 05708296140695 ()


  • Audiometric/hearing device software
DVD,FSW,RS AVENTA 3.10,US
Gn Hearing A/S
20327101
In Commercial Distribution

  • 05708296140688 ()


  • Audiometric/hearing device software
USB,FSW,RS AVENTA 3.10,US
Gn Hearing A/S
20316301
In Commercial Distribution

  • 05708296140145 ()


  • Audiometric/hearing device software
SW,FSW,BT SOLUS MAX 1.0
Gn Hearing A/S
20318700
In Commercial Distribution

  • 05708296140138 ()


  • Audiometric/hearing device software
SW,FSW,RS SMART FIT 1.0
Gn Hearing A/S
20318600
In Commercial Distribution

  • 05708296140121 ()


  • Audiometric/hearing device software
SW,FSW,RS AVENTA 3.10
Gn Hearing A/S
20316201
In Commercial Distribution

  • 05708296140084 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 AGX HEARING
Oticon A/S
204675
In Commercial Distribution

  • 05707131357847 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 VA
Oticon A/S
204671
In Commercial Distribution

  • 05707131357809 ()


  • Audiometric/hearing device software
GENIE 2 2019.2 OTICON
Oticon A/S
204670
In Commercial Distribution

  • 05707131357793 ()


  • Audiometric/hearing device software
GENIE 2 2018.2 OTICON
Oticon A/S
190057
In Commercial Distribution

  • 05707131339362 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2018.2 AGX HEARING
Oticon A/S
190064
In Commercial Distribution

  • 05707131339355 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2018.2 AVADA
Oticon A/S
190062
In Commercial Distribution

  • 05707131339348 ()


  • Audiometric/hearing device software
GENIE 2 2018.2 AUDIKA
Oticon A/S
190059
In Commercial Distribution

  • 05707131339324 ()


  • Audiometric/hearing device software
GENIE 2 2018.2 OTICON VA
Oticon A/S
190058
In Commercial Distribution

  • 05707131339317 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2017.2 AGX HEARING US
Oticon A/S
185799
In Commercial Distribution

  • 05707131335142 ()


  • Audiometric/hearing device software
GENIE 2 2017.2 VA US
Oticon A/S
185798
In Commercial Distribution

  • 05707131335135 ()


  • Audiometric/hearing device software
GENIE 2 2017.2
Oticon A/S
185795
In Commercial Distribution

  • 05707131335104 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2017.2 AVADA US
Oticon A/S
185794
In Commercial Distribution

  • 05707131335098 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2019.1 AGX HEARING
Oticon A/S
196708
In Commercial Distribution

  • 05707131345837 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2019.1 AVADA
Oticon A/S
196707
In Commercial Distribution

  • 05707131345820 ()


  • Audiometric/hearing device software
GENIE 2 2019.1 OTICON VA
Oticon A/S
196704
In Commercial Distribution

  • 05707131345790 ()


  • Audiometric/hearing device software
GENIE 2 2019.1 OTICON
Oticon A/S
196703
In Commercial Distribution

  • 05707131345783 ()


  • Audiometric/hearing device software
AMPLIFON GENIE 2, 2018.2 AMPLIFON
Oticon A/S
193881
In Commercial Distribution

  • 05707131343949 ()


  • Audiometric/hearing device software
GENIE 2016.2 NHS
Oticon A/S
183832
In Commercial Distribution

  • 05707131332172 ()


  • Audiometric/hearing device software
SELECTIC/NOVASENSE 2 2017.1
Oticon A/S
181798
In Commercial Distribution

  • 05707131330994 ()


  • Audiometric/hearing device software
SELECTIC/NOVASENSE 2017.1
Oticon A/S
181797
In Commercial Distribution

  • 05707131330987 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2 2017.1
Oticon A/S
181796
In Commercial Distribution

  • 05707131330970 ()


  • Audiometric/hearing device software
PRESCRIPTIVES 2017.1
Oticon A/S
181795
In Commercial Distribution

  • 05707131330963 ()


  • Audiometric/hearing device software
GENIE 2 VA 2017.1
Oticon A/S
181788
In Commercial Distribution

  • 05707131330932 ()


  • Audiometric/hearing device software
GENIE 2 2017.1
Oticon A/S
181787
In Commercial Distribution

  • 05707131330925 ()


  • Audiometric/hearing device software
GENIE VA 2017.1
Oticon A/S
181786
In Commercial Distribution

  • 05707131330918 ()


  • Audiometric/hearing device software
GENIE 2017.1
Oticon A/S
181785
In Commercial Distribution

  • 05707131330901 ()


  • Audiometric/hearing device software
AUDIKA GENIE 2 2017.1
Oticon A/S
181782
In Commercial Distribution

  • 05707131330895 ()


  • Audiometric/hearing device software
AUDIKA GENIE 2017.1
Oticon A/S
181781
In Commercial Distribution

  • 05707131330888 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2017.1
Oticon A/S
181780
In Commercial Distribution

  • 05707131330871 ()


  • Audiometric/hearing device software
AUDIGYFIT 2017.1
Oticon A/S
181779
In Commercial Distribution

  • 05707131330864 ()


  • Audiometric/hearing device software
OTICON USB GENIE 2 2016.2
Oticon A/S
177037
In Commercial Distribution

  • 05707131328939 ()


  • Audiometric/hearing device software
AVADA USB GENIE 2 2016.2
Oticon A/S
177036
In Commercial Distribution

  • 05707131328922 ()


  • Audiometric/hearing device software
AUDIGY USB GENIE 2 2016.2
Oticon A/S
177035
In Commercial Distribution

  • 05707131328915 ()


  • Audiometric/hearing device software
GENIE 2 VA 2016.2
Oticon A/S
176617
In Commercial Distribution

  • 05707131328496 ()


  • Audiometric/hearing device software
AUDIGYFIT 2 2016.2
Oticon A/S
176612
In Commercial Distribution

  • 05707131328441 ()


  • Audiometric/hearing device software
GENIE 2 2016.2
Oticon A/S
176611
In Commercial Distribution

  • 05707131328434 ()


  • Audiometric/hearing device software
DVD,AIRLINK 2 UPDATE,BT
Gn Hearing A/S
20538700
In Commercial Distribution

  • 05708296076765 ()


  • Audiometric/hearing device software
USB,FSW,BT SOLUS MAX 1.0,US
Gn Hearing A/S
20477900
In Commercial Distribution

  • 05708296078790 ()


  • Audiometric/hearing device software
DVD,FSW,BT SOLUS MAX 1.0,US
Gn Hearing A/S
20477800
In Commercial Distribution

  • 05708296078783 ()


  • Audiometric/hearing device software
USB,FSW,RS SMART FIT 1.0,US
Gn Hearing A/S
20231110
In Commercial Distribution

  • 05708296078769 ()


  • Audiometric/hearing device software
DVD,FSW,RS SMART FIT 1.0,US
Gn Hearing A/S
20231410
In Commercial Distribution

  • 05708296078752 ()


  • Audiometric/hearing device software
DVD,FSW,AUDIGY 1.0
Gn Hearing A/S
20474200
In Commercial Distribution

  • 05708296078745 ()


  • Audiometric/hearing device software
USB,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473500
In Commercial Distribution

  • 05708296078462 ()


  • Audiometric/hearing device software
DVD,FSW,RS AVENTA 3.10#2,US
Gn Hearing A/S
20473400
In Commercial Distribution

  • 05708296078455 ()


  • Audiometric/hearing device software
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