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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 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
Rapid System Update
Ischemaview, Inc.
6.1.0
In Commercial Distribution

  • B761R610 ()


  • Radiological PACS software
Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution

  • B761R60 ()


  • Radiological PACS 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
No Description
Edan Instruments, Inc.
Smart ECG Broker
In Commercial Distribution

  • 6944413808324 ()
  • 06944413808126 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
Insight
In Commercial Distribution

  • 06944413808072 ()


  • Electrocardiograph, professional, multichannel
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