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The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940756 ()
- Self-care monitoring/reporting software
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution
- EBCI80600 ()
- Electroencephalographic spectrum analyser
Rapid System Update
Ischemaview, Inc.
5.101
In Commercial Distribution
- B761R51011 ()
- Radiological PACS software
No Description
SUN NUCLEAR CORP.
159A
In Commercial Distribution
- B136159A0 ()
- Mammographic x-ray phantom, test object
Removal Tray Small Lid
Trimed, INC.
RMV-SMALL-LID
In Commercial Distribution
- 00842188126840 ()
RMV-SMALL-LID
- Instrument tray, reusable
Removal Tray Large Lid
Trimed, INC.
RMV-LARGE-LID
In Commercial Distribution
- 00842188126833 ()
RMV-LARGE-LID
- Instrument tray, reusable
K-Wire Guide 1.1mm
Trimed, INC.
WIRE-GUIDE
In Commercial Distribution
- 00842188114823 ()
WIRE-GUIDE
- Surgical drill guide, reusable
Wrist Fixation Set - Peg & Screw Caddy
Trimed, INC.
WFS-PS
In Commercial Distribution
- 00842188114816 ()
WFS-PS
- Instrument tray, reusable
Wrist Fixation Set - Lower Caddy, Volar Plates
Trimed, INC.
WFS-LWR
In Commercial Distribution
- 00842188114809 ()
WFS-LWR
- Instrument tray, reusable
Wrist Fixation Set - Upper Caddy, Wire Forms
Trimed, INC.
WFS-UPR
In Commercial Distribution
- 00842188114793 ()
WFS-UPR
- Instrument tray, reusable
Wrist System Tray (CLASSIC)
Trimed, INC.
WFS-TRAY (C)
In Commercial Distribution
- 00842188114786 ()
WFS-TRAY (C)
- Instrument tray, reusable
Tap - 3.2mm
Trimed, INC.
TAP-3.2
In Commercial Distribution
- 00842188114779 ()
TAP-3.2
- Bone tap, reusable
Tap - 2.3mm
Trimed, INC.
TAP-2.3
In Commercial Distribution
- 00842188114762 ()
TAP-2.3
- Bone tap, reusable
Peg Guide Extender Classic
Trimed, INC.
PEG-XTNDR (C)
In Commercial Distribution
- 00842188114755 ()
PEG-XTNDR (C)
- Orthopaedic implant aiming/guiding block attachment tool
GRIPR-3.2 Shaft
Trimed, INC.
GRIPR-3.2 SHAFT
In Commercial Distribution
- 00842188114748 ()
GRIPR-3.2 SHAFT
- Orthopaedic implantation sleeve, reusable
GRIPR-3.2 Mechanism
Trimed, INC.
GRIPR-3.2 MCH
In Commercial Distribution
- 00842188114731 ()
GRIPR-3.2 MCH
- Orthopaedic implantation sleeve, reusable
GRIPR-2.3 Shaft
Trimed, INC.
GRIPR-2.3 SHAFT
In Commercial Distribution
- 00842188114724 ()
GRIPR-2.3 SHAFT
- Orthopaedic implantation sleeve, reusable
GRIPR-2.3 Mechanism
Trimed, INC.
GRIPR-2.3 MCH
In Commercial Distribution
- 00842188114717 ()
GRIPR-2.3 MCH
- Orthopaedic implantation sleeve, reusable
Screwdriver - 3.2mm screw
Trimed, INC.
DRIVR-3.2
In Commercial Distribution
- 00842188114700 ()
DRIVR-3.2
- Surgical screwdriver, reusable
Screwdriver - 2.3mm screw
Trimed, INC.
DRIVR-2.3
In Commercial Distribution
- 00842188114694 ()
DRIVR-2.3
- Surgical screwdriver, reusable
Bearing Reduction Tool Classic
Trimed, INC.
BRT (C)
In Commercial Distribution
- 00842188114687 ()
BRT (C)
- Orthopaedic bone-reduction tool
Pin Plate Anchor
Trimed, INC.
ANCHOR
In Commercial Distribution
- 00842188114670 ()
ANCHOR
- Bone awl, reusable
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
1000-86
In Commercial Distribution
- 10841307119272 ()
1000-86
- Surgical screwdriver, reusable
Dental instruments designed for the placement and construction of a dental prostheses.
RHEIN 83 SRL
INSTRUMENT SET (CAI)
Not in Commercial Distribution
- D8210003 ()
- Dental implant suprastructure, permanent, preformed
accessories for image enhancement in diagnostic displays
Barco NV
2.X.X.X
In Commercial Distribution
- 05415334002050 ()
K9308260
- Radiology picture archiving and communication system workstation
The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings.
This device is designed only for adults.
AVITA CORPORATION
58460
In Commercial Distribution
- 04710953421635 ()
- 04710953421628 ()
- Automatic-inflation electronic sphygmomanometer, non-portable
UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.
SEPARATION TECHNOLOGY, INC.
320-113
In Commercial Distribution
- 00831829000366 ()
- 00831829000373 ()
320-113
- Wash/cleaning solution IVD, manual equipment
device that allows you to easily and safely check the diameter of ball couplings
RHEIN 83 SRL
MISURATORE DI SFERE
In Commercial Distribution
- 08059224161631 ()
008MDS
- Dental implant suprastructure, temporary, preformed, single-use
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.6
Not in Commercial Distribution
- 00864747000279 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.4
Not in Commercial Distribution
- 00864747000262 ()
- MRI system application software