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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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swiftPro System
EMBLATION LIMITED
SWF-MIC01
In Commercial Distribution

  • 05060652910053 ()
SWF-MIC01

  • Microwave hyperthermia system
The Swift® microwave generator is intended to be used with the Swift® applicator for the coagulation of soft tissue.
EMBLATION LIMITED
SWF-GE01
In Commercial Distribution

  • 05060652910008 ()
SWF-GE01

  • Microwave hyperthermia system
Prolieve Thermodilatation Single Use Kit
Medifocus, Inc.
Coude Tip Catheter
In Commercial Distribution

  • B0638808260 ()


  • Microwave hyperthermia system
Prolieve Thermodilatation System
Medifocus, Inc.
Original
In Commercial Distribution

  • B0638808060 ()


  • Microwave hyperthermia system
Focus Thermotherapy Device
Medifocus, Inc.
Original
In Commercial Distribution

  • B0634100145 ()


  • Microwave hyperthermia system
The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.
Pyrexar Medical Inc.
BSD-500
Not in Commercial Distribution



  • Microwave hyperthermia system
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
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-2000B
Not in Commercial Distribution



  • Microwave hyperthermia system
AMICA-GEN MW/RF GENERATOR 140W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08033055149280 ()
AGN-H-1.0

  • Microwave hyperthermia system
AMICA-GEN MW GENERATOR 140W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08033055149273 ()

  • Height: 13 Centimeter
  • Width: 47 Centimeter
  • Depth: 35 Centimeter
  • Weight: 10.5 Kilogram
AGN-3.0

  • Microwave hyperthermia system
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