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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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Kosmos OTS Android Linear Color - 09353278000694

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software

Kosmos OTS Android Linear - 09353278000687

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software

Member's Selection - 00812944029715

128 Ch Hearing Aid Universal for Android Beige
HEARING LAB TECHNOLOGY, LLC
5465
In Commercial Distribution

  • 00812944029715 ()
HLT-U128WLA-BG

  • Air-conduction hearing aid, receiver-in-the-ear

MapRT Web app - 05056190500887

MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app 1.1
In Commercial Distribution

  • 05056190500887 ()
MapRT Web app

  • Radiation therapy software

MapRT Web app - 05056190500771

MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app
In Commercial Distribution

  • 05056190500771 ()
MapRT Web app

  • Radiation therapy software

reSET-O® Demo Version (Mobile App, Android) - 10851580008248

reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008248 ()


  • Mental health/function therapeutic software, screen-viewed

reSET® Demo Version (Mobile App, Android) - 10851580008217

reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008217 ()


  • Mental health/function therapeutic software, screen-viewed

Cell Therapy 360 Wearable Tech V1 - 00851203006272

BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution

  • 00851203006272 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

ARIAL - 00840948103018

Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer

Empatica Health Monitoring Platform - 00853858006256

No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use
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