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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An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution

  • 07290018393147 ()


  • Configurable electronic form web-based application software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring
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