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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STARKEY LABORATORIES, INC.
Thrive Hearing Control for Android
In Commercial Distribution

  • 00842318130808 ()


  • Audiometric/hearing device software
hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
HEARX GROUP (PTY) LTD
hearScope
In Commercial Distribution

  • 00860003469828 ()


  • Otoscope, direct
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software
RESET-O is an Android application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as a adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433026 ()


  • Mental health/function therapeutic software, screen-viewed
Kinesis Gait consists of a device for assessment of gait and movement through quantitative analysis of gait using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950010 ()


  • Gait analysis system
Ear Wax Removal System. View and safely clean your ear canal. The bebird cleaning rod wireless connects to your apple or android phone or tablet allowing the user to see high resolution images of their outer ear canal.
Be Bird Usa, Inc
W3-WM-BK
In Commercial Distribution

  • 00850030574060 ()
HVRS

  • Otoscope, endoscopic
QTUG consists of a device for assessment of mobility, falls risk and frailty in older adults through quantitative analysis of movement using body-worn inertial sensors. The device streams data over a Bluetooth interface to an Android tablet device.
KINESIS
3.2.2
In Commercial Distribution

  • 05391542950003 ()


  • Gait analysis system
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution

  • B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Nova Chat 10.5 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10.1" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features.
PRENTKE ROMICH COMPANY
NC10.5
In Commercial Distribution

  • 00816486020360 ()

  • Weight: 1.95 Pound


  • Voice synthesizer/digitizer
Nova Chat 10.4 is a speech generating device with a 10 inch screen.NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10.1" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features.
PRENTKE ROMICH COMPANY
NC10.4
Not in Commercial Distribution

  • 00816486020353 ()

  • Weight: 1.95 Pound


  • Voice synthesizer/digitizer
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