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No Description
Get-Grin Inc.
W Version
In Commercial Distribution
- D962GGAW0002 ()
- Radiological PACS software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution
- D962GGAR0003 ()
- Radiological PACS software
No Description
Carl Zeiss Meditec AG
FORUM Viewer App
In Commercial Distribution
- 04049471100020 ()
- Patient health record information system application software
No Description
Brainlab AG
1.2
In Commercial Distribution
- 04056481145385 ()
- Multidisciplinary medical image management software
No Description
Brainlab AG
1.1
Not in Commercial Distribution
- 04056481144265 ()
- Multidisciplinary medical image management 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
Sonova AG
088-0021
In Commercial Distribution
- 07613389543254 ()
- Audiometric/hearing device 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 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
The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider.
The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan.
The Diary Mobile app is suited for both iPhone and Android users.
The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above
the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.
The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.
DREAMED DIABETES LTD
02.XX.YY
In Commercial Distribution
- 07290017735030 ()
N/A
- Clinical management support 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
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution
- 07290018393147 ()
- Configurable electronic form web-based application 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
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
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution
- 15694311111665 ()
- Sleep disorder interpretive software, professional-only
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
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution
- 00884838082137 ()
mSafe
- Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution
- 00884838082120 ()
mSafe
- Vulnerable patient home alert system
SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution
- 00721902865572 ()
- Multi-purpose stereotactic surgery system
APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution
- 05706069779714 ()
21035228
- Hearing aid/implant system remote control
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution
- 05706069779707 ()
21035227
- Hearing aid/implant system remote control
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
BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution
- 00851203006265 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution
- 00851203006258 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution
- 00851203006241 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution
- 00851203006234 ()
- Wireless patient monitor/sensor reporting software, layperson-use
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution
- 05706069674729 ()
5 300 0007 001
- Tinnitus masking application software
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution
- 05706069674712 ()
5 300 0006 001
- Tinnitus masking application software
BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution
- 05706069673579 ()
5 300 0005 001
- Hearing aid/implant system remote control
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution
- 05706069673562 ()
5 300 0004 001
- Hearing aid/implant system remote control
Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution
- 00858177007465 ()
Lexie Android App
- Audiometric/hearing device software
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution
- 00858177007458 ()
Lexie IOS App
- Audiometric/hearing device software
APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
In Commercial Distribution
- 05708296074259 ()
- Hearing aid/implant system remote control
APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution
- 05708296074242 ()
- Hearing aid/implant system remote control
APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
In Commercial Distribution
- 05708296074235 ()
- Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution
- 05708296074228 ()
- Hearing aid/implant system remote control
APP,RS SMART,3.4,ANDR
Gn Hearing A/S
20416600
In Commercial Distribution
- 05708296074211 ()
- Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution
- 05708296074204 ()
- Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution
- 05708296071548 ()
- Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution
- 05708296071531 ()
- Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,ANDR
Gn Hearing A/S
20409900
In Commercial Distribution
- 05708296071449 ()
- Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,IOS
Gn Hearing A/S
20409500
In Commercial Distribution
- 05708296071432 ()
- Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution
- 05708296070831 ()
- Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution
- 05708296070824 ()
- Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution
- 05708296070817 ()
- Hearing aid/implant system remote control