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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A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera. It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System. For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025094 ()
MAU-EG20004

  • Radiology information system application software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
APP,JABRA,ENHANCE,1.0.0,IOS
Gn Hearing A/S
22153200
In Commercial Distribution

  • 05708296229185 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,ANDR
Gn Hearing A/S
21820100
In Commercial Distribution

  • 05708296214655 ()


  • Hearing aid/implant system remote control
FW updater App 1.0.0 iOS
Sbo Hearing A/S
232872
In Commercial Distribution

  • 05714464033829 ()


  • Hearing aid wireless-fitting computer-aided set
Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution

  • 05708296071548 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control
BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution

  • 00851203006272 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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