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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Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
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