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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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Orpheus CAST App - 07290017025094

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

Relivion MG App - 07290018393147

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

Noxturnal US APP - 15694311111665

No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only

Tympa Mobile App - 25060753520070

No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer

Persona Medical - 00851362008087

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

RXEars - 00851362008025

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

3DIEMME RealGUIDE - 08050038830003

Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software

Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

DryGuardians - 07350078445160

No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
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