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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
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution
- 00860004366218 ()
- Electrocardiography telemetric monitoring system
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
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
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
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
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution
- 00884838082137 ()
mSafe
- Vulnerable patient home alert system
To be attached at the tube saw to provide the required torque to saw the bone.
OSTEOTEC LIMITED
OST-CBG-15
In Commercial Distribution
- 05060183095694 ()
OST-CBG-15
- Surgical instrument handle, non-torque-limiting
The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario
LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for
the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006154)
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178)
LABSTYLE INNOVATION LTD
1147-05
In Commercial Distribution
- 00850065006253 ()
- Glucose IVD, kit, enzyme spectrophotometry, rapid
- Glucose monitoring system IVD, home-use
3M™ Unitek™ How Utility Offset Pliers, 801-701, 1/Ea
3M UNITEK CORPORATION
801-707
In Commercial Distribution
- 00652221217820 ()
801-707
- Orthodontic pliers
Ligature pliers HOW Crovana 14 cm
Fig. 111, curved
BOX LOCK
A. Schweickhardt GmbH & Co. KG
5305
In Commercial Distribution
- E89653050 ()
5305
- Wire holding/twisting pliers
Ligature pliers HOW Crovana 14 cm
Fig. 110, straight
BOX LOCK
A. Schweickhardt GmbH & Co. KG
5304
In Commercial Distribution
- E89653040 ()
5304
- Wire holding/twisting pliers
HOW Wire Grasping Pliers, 5 1/2", (140 mm), non-sterile, reusable
Aesculap AG
DP393R
In Commercial Distribution
- 04038653038183 ()
DP393R
- Orthodontic pliers