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
Sonova AG
088-0021
In Commercial Distribution

  • 07613389543254 ()


  • Audiometric/hearing device software
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution

  • 07540191000586 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9013
In Commercial Distribution

  • 07540191000548 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA4502
In Commercial Distribution

  • 07540191000487 ()


  • Psychophysiological biofeedback 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 a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution

  • B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
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 IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
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
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
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution

  • 00810038851983 ()


  • Cardiopulmonary physiological parameter analysis software
A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera. It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System. For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025094 ()
MAU-EG20004

  • Radiology information system application software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
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