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 Class Implantable

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Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution

  • 07640161394780 ()
301251

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301250
In Commercial Distribution

  • 07640161394773 ()
301250

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301249
In Commercial Distribution

  • 07640161394766 ()
301249

  • Dental implant suprastructure, temporary, preformed, single-use
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
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
MA9162 IOS (Version 15)
In Commercial Distribution

  • 00300021286552 ()
MA9162001AM

  • 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
MA9160 IOS (Version 14)
In Commercial Distribution

  • 00300021284558 ()
MA9160001AM

  • 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
MA9158 IOS (Version 13)
In Commercial Distribution

  • 00300021177553 ()
MA9158001AM

  • 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
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software
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