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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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No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software
A mobile companion app for Bose® Hear products
BOSE CORPORATION
865924-0010
Not in Commercial Distribution

  • 00017817831918 ()


  • Air-conduction hearing aid, receiver-in-canal
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
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
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution

  • D16420251 ()


  • CAD/CAM software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
0.9.6
In Commercial Distribution

  • D16409625 ()


  • CAD/CAM software
No Description
Carl Zeiss Meditec AG
FORUM Viewer App
In Commercial Distribution

  • 04049471100020 ()


  • Patient health record information system application software
Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution

  • 00810099090819 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
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