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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Mistral-Air® Plus Warming Unit - SYK (110-120V)
The Surgical Company International B.V.
MA1100-PM
In Commercial Distribution

  • 18719867000038 ()


  • Circulating-air whole-body heating system control unit
Cocoon Convective Warming Machine, Model CWS7000
CARE ESSENTIALS PTY LTD
CWS7000
In Commercial Distribution

  • 09332017003264 ()
CWS7000-110

  • Circulating-air whole-body heating system control unit
Cocoon Warming Machine
CARE ESSENTIALS PTY LTD
CWS 5000
In Commercial Distribution

  • 09332017002007 ()
CWS5000-110

  • Circulating-air whole-body heating system control unit
Cocoon Warming Machine
CARE ESSENTIALS PTY LTD
CWS 4000
In Commercial Distribution

  • 09332017000553 ()
CWS4000-110

  • Circulating-air whole-body heating system control unit
The TintoRetriever Digital Pressure Cooker is a precision-controlled heat source capable of mantaining a constant and reliable temperature while minimizing the potential for evaporation of the working solution.
BIO SB, INC.
BSB 7015
In Commercial Distribution

  • B502BSB70150 ()
BSB 7015

  • Pressurized incubator IVD
Accessories of the TintoDetector Staining System
BIO SB, INC.
BSB 7002
In Commercial Distribution

  • B502BSB70020 ()
BSB 7002

  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DRY2008US
In Commercial Distribution

  • 00847627023551 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DC2012-R
In Commercial Distribution

  • 00847627023537 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DC2012-220V-R
In Commercial Distribution

  • 00847627023520 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DC2012-220V
In Commercial Distribution

  • 00847627023513 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DC2012
In Commercial Distribution

  • 00847627023506 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DCARC0001-R
In Commercial Distribution

  • 00847627030887 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DCARC0001
In Commercial Distribution

  • 00847627030870 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DCARC0003-R
In Commercial Distribution

  • 00847627035509 ()


  • Pressurized incubator IVD
No Description
BIOCARE MEDICAL LLC
DCARC0003
In Commercial Distribution

  • 00847627035493 ()


  • Pressurized incubator IVD
NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER, AIRLIFE FIT
PEGASUS RESEARCH CORPORATION
301-P2001CF
In Commercial Distribution

  • 00612223200121 ()

  • Outer Diameter: 4 Inch
  • Weight: 3 Pound
  • Height: 4.5 Inch
P2001CC

  • Benchtop nebulizer, heated
Self-heating adhesive heating patch 3.8 x 5.1 inch
Alva/Amco Pharmacal Companies, Inc.
A1750008
In Commercial Distribution

  • 00072959010751 ()
  • 10072959010758 ()
  • 60072959010753 ()


  • Exothermic heat therapy pack/patch
AirLife Adult Heating wire circuit single-limb, single-heated circuit
Carefusion Corporation
AH102
Not in Commercial Distribution

  • 50885403416666 ()
  • 10885403416668 ()
AH102

  • Ventilator breathing circuit, single-use
Conductive Heating Belt for model 22-033 TENS unit
VERIDIAN HEALTHCARE LLC
22-051
In Commercial Distribution

  • 00845717007924 ()
22-051

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
EMBLATION LIMITED
SWF-CRA01
In Commercial Distribution

  • 05060652910084 ()
SWF-CRA01

  • Microwave hyperthermia system
The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft tissue.
EMBLATION LIMITED
SWF-HAN01
In Commercial Distribution

  • 05060652910060 ()
SWF-HAN01

  • Microwave hyperthermia system
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
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
In Commercial Distribution



  • 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
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
In Commercial Distribution



  • Microwave hyperthermia system
Local Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-500
Not in Commercial Distribution

  • 00851551005194 ()


  • Microwave hyperthermia system
Deep Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-2000U
Not in Commercial Distribution

  • 00851551005187 ()


  • Tumour-therapy radio-frequency hyperthermia system
Deep Hyperthermia System (U.S.A.)
BSD MEDICAL CORPORATION
BSD-2000B
Not in Commercial Distribution

  • 00851551005170 ()


  • 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 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
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
RFA Generator,100 V
Covidien LP
CTRF 100
Not in Commercial Distribution

  • 10884524002774 ()


  • Tumour-therapy radio-frequency hyperthermia system
RFA Generator,117 V
Covidien LP
CTRF 117
Not in Commercial Distribution

  • 10884524001548 ()


  • 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
MWA Generator
Covidien LP
VTGEN
In Commercial Distribution

  • 10884524001579 ()


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

  • 10884521813014 ()

  • Power, 150, W;


  • Microwave hyperthermia system
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