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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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hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.
ONEFIT MEDICAL
2.x
Not in Commercial Distribution

  • 03700757200827 ()
/

  • Orthopaedic/craniofacial implantation planning software
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.
ONEFIT MEDICAL
3.x
In Commercial Distribution

  • 03700757200834 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839108 ()


  • Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839092 ()


  • Radiological PACS software
No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software
No Description
QYNAPSE
1.X
In Commercial Distribution

  • 03770016198004 ()


  • Radiology DICOM image processing 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
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

  • B553202192OTC0 ()


  • Home pharmaceutical management support 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

  • B553202191OTC0 ()


  • Home pharmaceutical management support software
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