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

Show Filters

PACS Scan Web
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007181 ()


  • Radiological PACS software
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007297 ()


  • Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007280 ()


  • Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007266 ()


  • Radiological PACS software
Core Server
HYLAND LLC
5.X
Not in Commercial Distribution

  • 00850677007259 ()


  • Radiological PACS software
Web Forms, Mod Link Web Forms
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007228 ()


  • Radiological PACS software
Mod LInk
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007211 ()


  • Radiological PACS software
PACSgear Core Server
HYLAND LLC
4.X
In Commercial Distribution

  • 00850677007167 ()


  • Radiological PACS software
  • Medical image management system
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software
No Description
Tilite
TiLite X
In Commercial Distribution

  • 00853316008129 ()


  • Push-rim manual wheelchair, non-bariatric
No Description
Tilite
Aero X
In Commercial Distribution

  • 00853316008068 ()


  • Push-rim manual wheelchair, non-bariatric
No Description
Sysmex America, Inc.
1.X
In Commercial Distribution

  • 00664369000851 ()


  • Clinical laboratory information system application software
No Description
Sysmex America, Inc.
5.X
In Commercial Distribution

  • 00664369000752 ()


  • Clinical laboratory information system
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution

  • 00852426007022 ()


  • CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution

  • 00852426007015 ()


  • CT system application software
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution

  • 00852426007008 ()


  • CT system application software
Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
GLOOKO, INC.
18.x
In Commercial Distribution

  • 00855093008019 ()


  • Clinical management support software
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution

  • 05902729753487 ()


  • Dental treatment application software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.2.x
In Commercial Distribution

  • 05902729753630 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.1.x
Not in Commercial Distribution

  • 05902729753500 ()


  • CAD/CAM software
Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution

  • 05902729752954 ()


  • Dental treatment application software
cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB). cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.
Combinostics Oy
1.0.x
In Commercial Distribution

  • 06430070845012 ()


  • Radiology DICOM image processing application software
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism. cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration. PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy. cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.
Combinostics Oy
1.0.x
In Commercial Distribution

  • 06430070844015 ()


  • Radiology DICOM image processing application software
https://www.combinostics.com/cmri/
Combinostics Oy
2.0.X
In Commercial Distribution

  • 06430070841021 ()


  • Radiology DICOM image processing application software
No Description
PaloDEx Group Oy
6.x
In Commercial Distribution

  • 06430035872367 ()
213248

  • Stationary panoramic/tomographic dental x-ray system, digital
No Description
PaloDEx Group Oy
11.x
In Commercial Distribution

  • 06430035872350 ()
213183

  • Stationary panoramic/tomographic dental x-ray system, digital
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE X
In Commercial Distribution

  • 06903053003902 ()


  • General-purpose ultrasound imaging system
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation materials.
PHYSIQ, INC
Model X
In Commercial Distribution

  • 00850023120212 ()


  • Electrocardiography telemetric monitoring system
The Via X Anti-Gravity Treadmill is intended to be a used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support.
Lifeward CA, Inc.
Via X
In Commercial Distribution

  • 00850022788031 ()


  • Pneumatic-support treadmill
The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support
Lifeward CA, Inc.
Fit X
In Commercial Distribution

  • 00850022788017 ()


  • Pneumatic-support treadmill
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution

  • 00850010298146 ()
ELEFT

  • Cardiopulmonary physiological parameter analysis software
Nitrile Examination Gloves
TEC GLOVES USA, LLC
X Large
In Commercial Distribution

  • 00860009233577 ()
  • 00860009233539 ()
TC21NXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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
No Description
Whoop, Inc.
1.x
In Commercial Distribution

  • 00860012964819 ()


  • Electrocardiograph, home-use
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution

  • 00860135001934 ()


  • Electronic acoustic stethoscope
No Description
SCIMAGE, INC
3.x
In Commercial Distribution

  • 00861917000305 ()


  • Radiological PACS software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution

  • 00859699006042 ()


  • Radiological PACS software
  • Patient health record information system
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000315 ()


  • Radiation therapy software
A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000308 ()


  • Radiology DICOM image processing application software
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution

  • 00860007599118 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution

  • 00860007599101 ()


  • Pathology information system
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
No Description
Aiq Global, Inc.
2.x
In Commercial Distribution

  • 00860007104916 ()


  • Radiological PACS software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
< 1 ... 100 101 102 103 104 ... 200 >