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

  • 00850016231390 ()


  • Audiometric/hearing device software
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software
US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android)
Tandem Diabetes Care, Inc.
1007112
In Commercial Distribution

  • 90850018992445 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
No Description
Tura Inc.
K581 CIN 58
In Commercial Distribution

  • 00764724859848 ()

  • Width: 58 Millimeter


  • Spectacle frame
No Description
Tura Inc.
K583 CIN 56
In Commercial Distribution

  • 00764724859800 ()

  • Width: 56 Millimeter


  • Spectacle frame
3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon)
Lifewatch
MCT 3L-Brigadier-Verizon
In Commercial Distribution

  • 00850725007026 ()


  • Electrocardiography telemetric monitoring system transmitter
Samsung Health Body Composition tracker for android OS smart watch
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938854 ()


  • Bioelectrical body composition analyser
Samsung Health Body Composition tracker for android OS smart phone
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938847 ()


  • Bioelectrical body composition analyser
3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)
Lifewatch
MCT 3L-Universal Gateway-Verizon
In Commercial Distribution

  • 00850725007033 ()


  • Electrocardiography telemetric monitoring system transmitter
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
Accent Bluetooth rechargeable 1401 - Android WH - 32 channel *Sam's Club 20218
ETYMOTIC RESEARCH, INC.
Accent 20218
In Commercial Distribution

  • 00846430006003 ()


  • Air-conduction hearing aid, in-the-ear
Eko mobile app for android international platforms for use with Eko medical devices.
Eko Devices, Inc.
com.ekodevices.android.intl
In Commercial Distribution

  • 00850010298061 ()


  • Medical equipment clinical data interfacing software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008125 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: - increase abstinence from a patient’s substances of abuse during treatment, and - increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008095 ()


  • Mental health/function therapeutic software, screen-viewed
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • Implantable glucose monitoring system
Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5504-06-300
In Commercial Distribution

  • 00817491024275 ()
FG-5504-06-300

  • Implantable glucose monitoring system
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