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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Total Talus, With Suture Hole, 105%
Restor3d, Inc.
1102-14
In Commercial Distribution

  • 00840097509822 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, With Suture Hole, 100%
Restor3d, Inc.
1102-13
In Commercial Distribution

  • 00840097509815 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, With Suture Hole, 95%
Restor3d, Inc.
1102-12
In Commercial Distribution

  • 00840097509808 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, With Suture Hole, 90%
Restor3d, Inc.
1102-11
In Commercial Distribution

  • 00840097509792 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 110%
Restor3d, Inc.
1102-05
In Commercial Distribution

  • 00840097509785 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 105%
Restor3d, Inc.
1102-04
In Commercial Distribution

  • 00840097509778 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 100%
Restor3d, Inc.
1102-03
In Commercial Distribution

  • 00840097509761 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 95%
Restor3d, Inc.
1102-02
In Commercial Distribution

  • 00840097509754 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 90%
Restor3d, Inc.
1102-01
In Commercial Distribution

  • 00840097509747 ()


  • Custom-made hand/foot bone prosthesis
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
Not in Commercial Distribution



  • Microwave hyperthermia system
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