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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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Prolieve - B0638808060

Prolieve Thermodilatation System
Medifocus, Inc.
Original
In Commercial Distribution

  • B0638808060 ()


  • Microwave hyperthermia system

Microfocus APA 1000 System - B0634100145

Focus Thermotherapy Device
Medifocus, Inc.
Original
In Commercial Distribution

  • B0634100145 ()


  • Microwave hyperthermia system

Microwave Ablation Generator - 06954414610024

Microwave Ablation Generator
Canyon Medical Inc.
KY-2000A
In Commercial Distribution

  • 06954414610024 ()


  • Microwave hyperthermia system

Microwave Ablation Generator - 06954414674453

Microwave Ablation Generator
Canyon Medical Inc.
KY-2100A
In Commercial Distribution

  • 06954414674453 ()


  • Microwave hyperthermia system

BSD-500 Hyperthermia System - 08644450004342

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

BSD-2000 Hyperthermia System - 08644450004106

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

BSD-2000 Hyperthermia System - 08644450004038

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

HS AMICA - 08033055149280

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

HS AMICA - 08033055149273

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

NovaSure - 15420045500853

No Description
Hologic, Inc.
NovaSure Controller
In Commercial Distribution

  • 15420045500853 ()


  • Tumour-therapy radio-frequency hyperthermia system
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