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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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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

  • 08806094940763 ()


  • Self-care monitoring/reporting software
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
Samsung Health Body Composition tracker for android OS smart watch
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938854 ()


  • Bioelectrical body composition analyser
Samsung Health Body Composition tracker for android OS smart phone
Samsung Electronics Co., Ltd.
1.x
Not in Commercial Distribution

  • 08806092938847 ()


  • Bioelectrical body composition analyser
No Description
SYRMA JOHARI MEDTECH LIMITED
X Trainer
In Commercial Distribution

  • 08908008085055 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
No Description
SYRMA JOHARI MEDTECH LIMITED
X FORCE
In Commercial Distribution

  • 08908008085048 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BONRAYBIO CO., LTD.
X QC
In Commercial Distribution

  • 04719874740733 ()


  • Sperm concentration indicator IVD, control
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution

  • 00628011382184 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution

  • 00628011382177 ()


  • Radiation therapy software
AIRFLOW PLUS
E.M.S. Electro Medical Systems S.A.
DV-165/X
In Commercial Distribution

  • 07613353208264 ()


  • Dental abrasive powder
No Description
M2S, INC.
4.x
Not in Commercial Distribution

  • B119PREVIEW0 ()


  • Radiology information system application software
No Description
H & O Equipments SA
CryoProbe|x
In Commercial Distribution

  • B386SHOCXPRXX8010 ()
S-HO-CXPR-XX-801

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe|x+
In Commercial Distribution

  • B386SHOCXPRP000 ()
S-HO-CXPRP-00

  • General cryosurgical system, cryogen gas, mechanical
CapSure Cloud is a secure cloud-based web application for medical image archiving and management.
Globalmed Holdings, LLC
2.1.x
Not in Commercial Distribution

  • B377GMR1602008X0 ()


  • Multidisciplinary medical image management software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution

  • B553202202OTC0 ()


  • Medication reminder application software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution

  • B553202201OTC0 ()


  • Medication reminder application software
Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help patients live well with their rare conditions and comorbidities. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as blood pressure monitors, activity trackers, and weight scales as well as self reported health information. The software provides educational content to encourage behaviors which may help living well with rare conditions and comorbidities based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
In Commercial Distribution

  • B553202195OTC0 ()


  • Medication reminder application software
Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help patients live well with their rare conditions and comorbidities. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as blood pressure monitors, activity trackers, and weight scales as well as self reported health information. The software provides educational content to encourage behaviors which may help living well with rare conditions and comorbidities based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
In Commercial Distribution

  • B553202194OTC0 ()


  • Medication reminder application software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution

  • B553202193OTC0 ()


  • Home pharmaceutical management support software
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