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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Ultrasound -guided intrauterine electrosurgical system ultrasound control unit
Gynesonics, Inc.
USCON-2200
In Commercial Distribution

  • 10817929020197 ()
USCON-2200

  • Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit
No Description
STARMED CO.,LTD
7-VENI0070N
In Commercial Distribution

  • 18809306767872 ()
  • 08809306767875 ()
  • 28809306767879 ()


  • Peripheral vascular radio-frequency ablation catheter
No Description
STARMED CO.,LTD
3-VENI0030N
In Commercial Distribution

  • 18809306767865 ()
  • 08809306767868 ()
  • 28809306767862 ()


  • Peripheral vascular radio-frequency ablation catheter
No Description
STARMED CO.,LTD
3-VENI003090N
In Commercial Distribution

  • 18809306764871 ()
  • 08809306764874 ()
  • 28809306764878 ()


  • Peripheral vascular radio-frequency ablation catheter
No Description
STARMED CO.,LTD
7-VENI007090N
In Commercial Distribution

  • 18809306764017 ()
  • 08809306764010 ()
  • 28809306764014 ()


  • Peripheral vascular radio-frequency ablation catheter
STYLET RFS2-6-12 CLOSUREFAST
MEDTRONIC, INC.
RFS2-6-12
In Commercial Distribution

  • 00763000723293 ()

  • Maximum electrode diameter: 6 Fr
  • Length: 12.0 Centimeter


  • Peripheral vascular radio-frequency ablation catheter
RF ARTHROSCOPY PROBE SAPHYRE BIPOLAR ABLATION 60 DEGREE W/SUCTION
STERILMED, INC.
SMI7209682
Not in Commercial Distribution

  • 10888551034494 ()
SMI7209682

  • Endoscopic electrosurgical electrode, bipolar, reprocessed
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-02
In Commercial Distribution

  • 05415067046673 ()
ENSITE-TFM-02

  • Cardiac mapping system application software
C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1032
In Commercial Distribution

  • 00854924006323 ()
FG-1032

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Controller for Full and Swipe C2 CryoBalloon Ablation System (translating)
C2 THERAPEUTICS, INC.
FG-1006
In Commercial Distribution

  • 00854924006064 ()
FG-1006

  • High-pressure medical gas hose
  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1033
In Commercial Distribution

  • 00854924006330 ()
FG-1033

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Temperature Sensor - Use only with IceCure Cryogenic device
ICECURE MEDICAL LTD
FAT8000000
Not in Commercial Distribution

  • 07290015487061 ()

  • Shaft Length: 170 Millimeter
  • Needle Gauge: 14 Gauge
FAT8000000

  • Cryosurgical system temperature probe
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The single connection cooling tube is for use with one bipolar RF needle with a product code of SP-CS.
AXON SRL
SP-CS
In Commercial Distribution

  • 00860011603696 ()


  • Percutaneous radio-frequency ablation probe cooling tubing set
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The double connection cooling tube is for use with two bipolar RF needles with a product code of SP-CD.
AXON SRL
SP-CD
In Commercial Distribution

  • 00860011603627 ()


  • Percutaneous radio-frequency ablation probe cooling tubing set
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046640
In Commercial Distribution

  • 08714729861904 ()

  • 2286 cm Length
M0046640

  • Cardiac ablation system cable, reusable
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046630
In Commercial Distribution

  • 08714729861898 ()

  • 1524 cm Length
M0046630

  • Cardiac ablation system cable, reusable
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046620
In Commercial Distribution

  • 08714729861881 ()

  • 762 cm Length
M0046620

  • Cardiac ablation system cable, reusable
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046610
In Commercial Distribution

  • 08714729861874 ()

  • 610 cm Length
M0046610

  • Cardiac ablation system cable, reusable
RF ARTHROSCOPY PROBE ABLATOR-S MONOPOLAR ABLATION 90DEG W/SUCTION BLACK SHAFT
STERILMED, INC.
SMI7209654
Not in Commercial Distribution

  • 10888551034463 ()
SMI7209654

  • Endoscopic electrosurgical electrode, monopolar, single-use
VULCAN SAPHYRE II ABLATION PROBE WITH SUCTION, 90 DEGREE, PEWTER SHAFT
Smith & Nephew, Inc.
7210111
In Commercial Distribution

  • 03596010481498 ()
7210111

  • Stereotactic surgery system probe, reusable
ELMED HYDRO THERMAL ABLATION FIBEROPTIC ENDOSCOPE WITH SCOPE ADAPTER, 3.0MM DIA
ELMED INCORPORATED
52-4211
In Commercial Distribution

  • 00842180135970 ()
52-4211

  • Rigid endoscope telescope
Ablation Cable from SMARTABLATE System to CELSIUS Catheter (TC/THR), 10'
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution

  • 07613327515787 ()

  • Length: 10.0 Feet
D130302

  • Electrical-only medical device connection cable, reprocessed
Aliya Generator - recertified
Galvanize Therapeutics, Inc.
GTI-00017R
In Commercial Distribution

  • 00850031859104 ()


  • Irreversible electroporation system generator
Aliya Generator, 2.5
Galvanize Therapeutics, Inc.
GTI-00017
In Commercial Distribution

  • 00850031859043 ()


  • Irreversible electroporation system generator
Single Electrode Probe Spacer
ANGIODYNAMICS, INC.
20400301
In Commercial Distribution

  • H787204003015 ()
  • H787204003010 ()
  • 15051684017954 ()


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode 5 Probe Pack - Activation
ANGIODYNAMICS, INC.
20400111
In Commercial Distribution

  • 15051684029643 ()
  • H787204001110 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400110
In Commercial Distribution

  • H787204001100 ()
  • 15051684017947 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400109
In Commercial Distribution

  • H787204001090 ()
  • 15051684017930 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400108
In Commercial Distribution

  • H787204001080 ()
  • 15051684017923 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400107
In Commercial Distribution

  • H787204001070 ()
  • 15051684017916 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400106
Not in Commercial Distribution

  • H787204001065 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400106
In Commercial Distribution

  • H787204001060 ()
  • 15051684017909 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Single Electrode Activation Probe
ANGIODYNAMICS, INC.
20400105
Not in Commercial Distribution

  • H787204001055 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Single Electrode Activation Probe
ANGIODYNAMICS, INC.
20400105
In Commercial Distribution

  • H787204001050 ()
  • 15051684017893 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400104
Not in Commercial Distribution

  • H787204001045 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400104
In Commercial Distribution

  • H787204001040 ()
  • 15051684017886 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Single Electrode Activation Probe
ANGIODYNAMICS, INC.
20400103
Not in Commercial Distribution

  • H787204001035 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Single Electrode Activation Probe
ANGIODYNAMICS, INC.
20400103
In Commercial Distribution

  • H787204001030 ()
  • 15051684017879 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400102
Not in Commercial Distribution

  • H787204001025 ()

  • Length: 25 Centimeter


  • Irreversible electroporation system
NanoKnife Disposable Single Electrode Probe
ANGIODYNAMICS, INC.
20400101
Not in Commercial Distribution

  • H787204001015 ()

  • Length: 15 Centimeter


  • Irreversible electroporation system
NanoKnife Generator 3.0
ANGIODYNAMICS, INC.
20300301US
In Commercial Distribution

  • H78720300301US0 ()
  • 15051684013727 ()


  • Irreversible electroporation system
NanoKnife Generator
ANGIODYNAMICS, INC.
20300101-US
In Commercial Distribution

  • H78720300101US0 ()


  • Irreversible electroporation system
NanoKnife Generator
ANGIODYNAMICS, INC.
20300101
In Commercial Distribution

  • H787203001010 ()


  • Irreversible electroporation system
Aliya Electrode, 5 pack
Galvanize Therapeutics, Inc.
GTI-00024
In Commercial Distribution

  • 10850031859026 ()
  • 00850031859029 ()


  • Irreversible electroporation system probe connection electrode
Aliya Needle, 5 pack
Galvanize Therapeutics, Inc.
GTI-00023
In Commercial Distribution

  • 10850031859002 ()
  • 00850031859005 ()


  • Irreversible electroporation system percutaneous probe
ARTHROSCOPY PACK
Aligned Medical Solutions
AMS11839
In Commercial Distribution

  • B098AMS118391 ()
  • B098AMS118390 ()
AMS11839

  • Orthopaedic surgical procedure kit, non-medicated, single-use
GENERATOR 40-404-1 AQM3 NON ROHS
MEDTRONIC, INC.
40-404-1
Not in Commercial Distribution

  • 00643169535442 ()


  • Electrosurgical system generator
AEX GENERATOR 40-405-1 US
MEDTRONIC, INC.
40-405-1
In Commercial Distribution

  • 00643169531048 ()


  • Electrosurgical system generator
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