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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iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
APP, Bluetooth, otoTune Android for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990020-SWH
In Commercial Distribution

  • 00850016231390 ()


  • Audiometric/hearing device software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
No Description
NXSTAGE MEDICAL, INC.
NX3094
Not in Commercial Distribution

  • 00842289101883 ()


  • Medical equipment clinical data interfacing software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_APP
Not in Commercial Distribution

  • 15694311110019 ()
536210

  • Sleep disorder interpretive software, professional-only
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software
Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
Libre IOS App US
ABBOTT DIABETES CARE INC
78746-01
In Commercial Distribution

  • 00357599841003 ()
78746-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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