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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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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

Solero - H787127401380

Solero MTA Cart
ANGIODYNAMICS, INC.
H787127401380
In Commercial Distribution

  • H787127401380 ()
  • 15051684000512 ()


  • Microwave hyperthermia system

Solero - H78712740000US0

MTA System
ANGIODYNAMICS, INC.
12740000US
In Commercial Distribution

  • H78712740000US0 ()
  • 15051684028219 ()


  • Microwave hyperthermia system

Emprint HP - 10884521781276

Ablation Generator with Thermosphere Technology 150W
Covidien LP
CAGENHP
In Commercial Distribution

  • 10884521781276 ()


  • Microwave hyperthermia system

Emprint - 10884521552586

Ablation Pump
Covidien LP
CAPUMP1ZD
In Commercial Distribution

  • 10884521552586 ()


  • Microwave hyperthermia system

Emprint - 10884521552579

Ablation Generator with Thermospher Technology
Covidien LP
CAGEN1ZD
In Commercial Distribution

  • 10884521552579 ()


  • Microwave hyperthermia system

Emprint HP - 10884521850033

Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking.
Covidien LP
CAGENHP
In Commercial Distribution

  • 10884521850033 ()

  • Power,150,Watt;


  • Microwave hyperthermia system

Emprint HP - 10884521813014

Ablation Generator with Thermosphere (TM) Technology
Covidien LP
CAGENHPZD
In Commercial Distribution

  • 10884521813014 ()

  • Power, 150, W;


  • Microwave hyperthermia system
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