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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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Water-Based Personal Lubricant
CC Wellness LLC
10121
In Commercial Distribution

  • 10796494000059 ()
  • 00796494000052 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
10119
In Commercial Distribution

  • 20796494000049 ()
  • 00796494000045 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
10118
In Commercial Distribution

  • 20796494000032 ()
  • 00796494000038 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
10117
In Commercial Distribution

  • 10796494000028 ()
  • 00796494000021 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
41021
In Commercial Distribution

  • 10796494000011 ()
  • 00796494000014 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
74112
In Commercial Distribution

  • 10796494741129 ()
  • 00796494741122 ()


  • Sexual lubricant
Hybrid-Based Personal Lubricant
CC Wellness LLC
74110
In Commercial Distribution

  • 30796494741109 ()
  • 00796494741108 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
40844
In Commercial Distribution

  • 10796494408442 ()
  • 00796494408445 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
40166
In Commercial Distribution

  • 10796494401665 ()
  • 00796494401668 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
79031-IH
In Commercial Distribution

  • 10796494790318 ()
  • 00796494790311 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
79030-IH
In Commercial Distribution

  • 10796494790301 ()
  • 00796494790304 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
79029-IH
In Commercial Distribution

  • 10796494790295 ()
  • 00796494790298 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
40819S
In Commercial Distribution

  • 10796494408190 ()
  • 00796494408193 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
72287
In Commercial Distribution

  • 10796494722876 ()
  • 00796494722879 ()


  • Sexual lubricant
Water-Based Personal Lubricant
CC Wellness LLC
49046
In Commercial Distribution

  • 10796494490461 ()
  • 00796494490464 ()


  • Sexual lubricant
prolaio medical device data system mobile application
Prolaio, Inc.
DP-22-06
In Commercial Distribution

  • 00850071330007 ()


  • Electrocardiography monitoring system receiver
No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software
Jacoti Listen App 2.X
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution

  • 05407004250014 ()


  • Air-conduction hearing aid, wearable case
myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to clinicians • Facilitates review of past measurements • Allows secure communication between patient and clinician
Endotronix, Inc.
100256-02
In Commercial Distribution

  • 00850008997037 ()


  • Bedside monitor remote-viewing software, physiological parameter
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
Windows PC Application for use with Eko products.
Eko Devices, Inc.
1.2.4
In Commercial Distribution

  • 00863609000358 ()


  • Medical equipment clinical data interfacing software
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution

  • 00860004366218 ()


  • Electrocardiography telemetric monitoring system
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649286 ()


  • Cardiopulmonary physiological parameter analysis software
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home 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
SPM01A2
In Commercial Distribution

  • 08051122040933 ()
SPM01A2

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
A mobile companion app for Bose® Hear products
BOSE CORPORATION
865924-0010
Not in Commercial Distribution

  • 00017817831918 ()


  • Air-conduction hearing aid, receiver-in-canal
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution

  • 09321502053006 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • Audiometric/hearing device software
DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049932 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051331 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049086 ()
1101478

  • Self-care monitoring/reporting software
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 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
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software
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