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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Ablation Generator with Thermospher Technology
Covidien LP
CAGEN1ZD
In Commercial Distribution

  • 10884521552579 ()


  • Microwave hyperthermia system
RFA Generator 117 V
Covidien LP
CTRF 117ZE
Not in Commercial Distribution

  • 10884521133198 ()


  • Tumour-therapy radio-frequency hyperthermia system
RFA Generator 117 V
Covidien LP
CTRF 117ZD
In Commercial Distribution

  • 10884521133181 ()


  • Tumour-therapy radio-frequency hyperthermia system
RFA Switching Controller
Covidien LP
CTSW Control ZD
In Commercial Distribution

  • 10884521165779 ()


  • Tumour-therapy radio-frequency hyperthermia system
RFA Generator,220 V
Covidien LP
CTRF 220
Not in Commercial Distribution

  • 10884524002781 ()


  • Tumour-therapy radio-frequency hyperthermia system
RFA Generator,100 V
Covidien LP
CTRF 100
Not in Commercial Distribution

  • 10884524002774 ()


  • Tumour-therapy radio-frequency 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
LCS Unit
ANGIODYNAMICS UK LIMITED
806-011
Not in Commercial Distribution

  • H787806011US0 ()


  • Microwave hyperthermia system
SulisVpMTA Generator
ANGIODYNAMICS UK LIMITED
806-010
Not in Commercial Distribution

  • H787806010US0 ()


  • Microwave hyperthermia system
Solero MTA Cart
ANGIODYNAMICS, INC.
H787127401380
In Commercial Distribution

  • H787127401380 ()
  • 15051684000512 ()


  • Microwave hyperthermia system
MTA System
ANGIODYNAMICS, INC.
12740000US
In Commercial Distribution

  • H78712740000US0 ()
  • 15051684028219 ()


  • Microwave hyperthermia system
MWA Generator
Covidien LP
VTGEN
In Commercial Distribution

  • 10884524001579 ()


  • Microwave hyperthermia system
RFA Generator,117 V
Covidien LP
CTRF 117
Not in Commercial Distribution

  • 10884524001548 ()


  • Tumour-therapy radio-frequency 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
Ablation Generator with Thermosphere (TM) Technology
Covidien LP
CAGENHPZD
In Commercial Distribution

  • 10884521813014 ()

  • Power, 150, W;


  • Microwave hyperthermia system
Ablation Generator with Thermosphere Technology 150W
Covidien LP
CAGENHP
In Commercial Distribution

  • 10884521781276 ()


  • Microwave hyperthermia system
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
AMICA-GEN MW GENERATOR 250W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983744864 ()
AGN-3.3

  • Microwave hyperthermia system
AMICA-GEN MW/RF GENERATOR 250W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983744772 ()
AGN-H-1.3

  • Microwave hyperthermia system
AMICA-GEN MW/RF GENERATOR 190W/200W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983742488 ()
AGN-H-1.2

  • Microwave hyperthermia system
AMICA-GEN MW GENERATOR 190W
H.S. HOSPITAL SERVICE SPA
AMICA-GEN
In Commercial Distribution

  • 08058983742471 ()
AGN-3.2

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

  • 08058983742457 ()
AGN-H-1.1

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

  • 08058983742068 ()

  • Weight: 10.5 Kilogram
  • Depth: 35 Centimeter
  • Width: 47 Centimeter
  • Height: 13 Centimeter
AGN-3.1

  • Microwave hyperthermia system
RFA Switching Controller
Covidien LP
CTSW Control
Not in Commercial Distribution

  • 10884524002798 ()


  • Tumour-therapy radio-frequency hyperthermia system
Microwave Ablation Generator
Canyon Medical Inc.
KY-2100A
In Commercial Distribution

  • 06954414674453 ()


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

  • 06954414610024 ()


  • Microwave hyperthermia system
No Description
Hologic, Inc.
NovaSure Controller
In Commercial Distribution

  • 15420045500853 ()


  • Tumour-therapy radio-frequency hyperthermia system
PST500 Integrated Warming Pad
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083521
In Commercial Distribution

  • 00850011479629 ()
2083521

  • Electric pad whole-body heating system
TS7000 Integrated Warming Pad
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083520
In Commercial Distribution

  • 00850011479612 ()
2083520

  • Electric pad whole-body heating system
Universal Warming Blanket
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083519
In Commercial Distribution

  • 00850011479605 ()
2083519

  • Electric pad whole-body heating system
Lower Body Warming Blanket
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083518
In Commercial Distribution

  • 00850011479599 ()
2083518

  • Electric pad whole-body heating system
Temperature Management Controller MP
AUGUSTINE TEMPERATURE MANAGEMENT LLC
2083516
In Commercial Distribution

  • 00850011479582 ()
2083516

  • Electric pad whole-body heating system
HotDog Temperature Management Controller - Multiport
AUGUSTINE TEMPERATURE MANAGEMENT LLC
WC77
In Commercial Distribution

  • 00850011479025 ()
WC77

  • Electric pad whole-body heating system
HotDog Temperature Management Controller - Single Port
AUGUSTINE TEMPERATURE MANAGEMENT LLC
WC71
In Commercial Distribution

  • 00850011479018 ()
WC71

  • Electric pad whole-body heating system
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