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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 Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
MNT WND.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272709 ()


  • Wound management image-analysis software
The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.G25
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272556 ()


  • Wound management image-analysis software
The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.GEN
In Commercial Distribution

  • 17290017272501 ()
  • 07290017272504 ()


  • Wound management image-analysis software
No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481142186 ()


  • Radiological PACS software
  • Stereotactic system application software
No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481140816 ()


  • Radiological PACS software
  • Stereotactic system application software
No Description
Brainlab AG
1.0
In Commercial Distribution

  • 04056481138530 ()


  • Radiological PACS software
  • Stereotactic system application software
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery. The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
2.3 Matera
In Commercial Distribution

  • 04260521365002 ()


  • Dental treatment application software
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery. The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
3.1 Rijeka
In Commercial Distribution

  • 04260521365026 ()


  • Dental treatment application software
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