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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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SW,FSW,CS SMART FIT 1.8
Gn Hearing A/S
21571900
In Commercial Distribution

  • 05708296195152 ()


  • Audiometric/hearing device software
SW,FSW,AUDIGY 2.6 #1
Gn Hearing A/S
21570700
In Commercial Distribution

  • 05708296195114 ()


  • Audiometric/hearing device software
No Description
Hyperfine Operations, Inc.
Version 1.0
In Commercial Distribution

  • 00860000606189 ()


  • Image segmentation application software
EXPRESSFIT 2017
Sonic Innovations, Inc.
181783
In Commercial Distribution

  • 05711583029993 ()


  • Audiometric/hearing device software
No Description
Eyenuk, Inc.
2.1.0
In Commercial Distribution

  • 00860000470001 ()


  • Retinal image analysis software
USB,FSW XB1.15,US,UP2
Gn Hearing A/S
22749000
In Commercial Distribution

  • 05708296279630 ()


  • Audiometric/hearing device software
USB,FSW AG2.15,AG1,US,UP2
Gn Hearing A/S
22748800
In Commercial Distribution

  • 05708296279616 ()


  • Audiometric/hearing device software
USB,FSW SM1.15,SP1,US,UP2
Gn Hearing A/S
22748400
In Commercial Distribution

  • 05708296279579 ()


  • Audiometric/hearing device software
SW,FSW SOLUS MAX 1.15,UP2
Gn Hearing A/S
22748300
In Commercial Distribution

  • 05708296279562 ()


  • Audiometric/hearing device software
USB,FSW SF1.15,AV3,US,UP2
Gn Hearing A/S
22748200
In Commercial Distribution

  • 05708296279555 ()


  • Audiometric/hearing device software
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