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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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myPhonak 4.0 app
Sonova AG
088-0013-17
In Commercial Distribution

  • 07613389403053 ()
088-0013-17

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-25
In Commercial Distribution

  • 07613389403046 ()
088-0013-25

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-97
In Commercial Distribution

  • 07613389403039 ()
088-0013-97

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-05
In Commercial Distribution

  • 07613389403022 ()
088-0013-05

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-13
In Commercial Distribution

  • 07613389403015 ()
088-0013-13

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-27
In Commercial Distribution

  • 07613389403008 ()
088-0013-27

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-20
In Commercial Distribution

  • 07613389402995 ()
088-0013-20

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-01
In Commercial Distribution

  • 07613389402988 ()
088-0013-01

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-04
In Commercial Distribution

  • 07613389402971 ()
088-0013-04

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-11
In Commercial Distribution

  • 07613389402964 ()
088-0013-11

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-02
In Commercial Distribution

  • 07613389402957 ()
088-0013-02

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-07
In Commercial Distribution

  • 07613389402940 ()
088-0013-07

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-08
In Commercial Distribution

  • 07613389402933 ()
088-0013-08

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-45
In Commercial Distribution

  • 07613389402926 ()
088-0013-45

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-15
In Commercial Distribution

  • 07613389402919 ()
088-0013-15

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013
In Commercial Distribution

  • 07613389402810 ()
088-0013

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-18
In Commercial Distribution

  • 07613389399301 ()
088-0013-18

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-70
In Commercial Distribution

  • 07613389399295 ()
088-0013-70

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-24
In Commercial Distribution

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-21
In Commercial Distribution

  • 07613389399271 ()
088-0013-21

  • Audiometric/hearing device software
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer
TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer
Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
Unity Discover App
PRENTKE ROMICH COMPANY
Unity
In Commercial Distribution

  • 00816486021633 ()


  • Voice synthesizer/digitizer
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9141 Android (Version 17)
In Commercial Distribution

  • 00300021458553 ()
MA9141001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9142 IOS (Version 17)
In Commercial Distribution

  • 00300021451554 ()
MA9142001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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