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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Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701338
In Commercial Distribution

  • 05415067013385 ()
H701338

  • Electrical-only medical device connection cable, reusable
Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701337
In Commercial Distribution

  • 05415067013378 ()
H701337

  • Electrical-only medical device connection cable, reusable
Generator Kit
ST. JUDE MEDICAL, INC.
H700494
In Commercial Distribution

  • 05415067004949 ()
H700494

  • Cardiac radio-frequency ablation system generator
Generator and Remote Control
ST. JUDE MEDICAL, INC.
H700492
In Commercial Distribution

  • 05415067004925 ()
H700492

  • Cardiac radio-frequency ablation system generator
Remote Control
ST. JUDE MEDICAL, INC.
Remote Control
In Commercial Distribution

  • 05415067004901 ()
H700490

  • Cardiac radio-frequency ablation system generator
Generator
ST. JUDE MEDICAL, INC.
H700488
In Commercial Distribution

  • 05415067004888 ()
H700488

  • Cardiac radio-frequency ablation system generator
HeartLight X3 Disposable Motor Catheter
CARDIOFOCUS, INC.
18-5000
In Commercial Distribution

  • 00859373007433 ()

  • Catheter Gauge: 12 French
18-5000

  • Cardiac ablation laser system beam guide-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
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
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
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
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
Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OSH
In Commercial Distribution

  • 10840143904127 ()
  • 30840143903360 ()
  • 50840143900073 ()
A001144

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OLH
In Commercial Distribution

  • 10840143904110 ()
  • 30840143903353 ()
  • 50840143900066 ()
A001143

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OSH
In Commercial Distribution

  • 30840143904817 ()
  • 10840143905995 ()
  • 50840143904071 ()
  • 10840143905209 ()
A001144SB

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OLH
In Commercial Distribution

  • 10840143905834 ()
  • 10840143905193 ()
  • 30840143904800 ()
  • 50840143904064 ()
A001143SB

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OSH
In Commercial Distribution

  • 10840143905209 ()
  • 30840143904121 ()
  • 50840143903777 ()
  • 10840143904127 ()
A001144SB

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OLH
In Commercial Distribution

  • 30840143904114 ()
  • 10840143905193 ()
  • 50840143903760 ()
  • 10840143904110 ()
A001143SB

  • Cardiac radio-frequency ablation system generator
NEUWAVE Arm 2 Dovetail Rail
NEUWAVE MEDICAL, INC.
ARM2
In Commercial Distribution

  • 00853719006982 ()
ARM2

  • Microwave ablation system generator
NEUWAVE Arm 1 OR Table Rail
NEUWAVE MEDICAL, INC.
ARM1
In Commercial Distribution

  • 00853719006975 ()
ARM1

  • Microwave ablation system generator
Surgical PDM Mount Kit
NEUWAVE MEDICAL, INC.
PD2MSURG
In Commercial Distribution

  • 00853719006524 ()
PD2MSURG

  • Microwave ablation system generator
CT Bed Rail Mount, Siemens Alt
NEUWAVE MEDICAL, INC.
CTBKT4
In Commercial Distribution

  • 00853719006487 ()

  • Depth: 88 Millimeter
  • Width: 645 Millimeter
CTBKT4

  • Microwave ablation system generator
CT Bed Rail Mount, Toshiba
NEUWAVE MEDICAL, INC.
CTBKT3
In Commercial Distribution

  • 00853719006470 ()

  • Width: 656 Millimeter
  • Depth: 48 Millimeter
CTBKT3

  • Microwave ablation system generator
CT Bed Rail Mount, Siemens
NEUWAVE MEDICAL, INC.
CTBKT2
In Commercial Distribution

  • 00853719006463 ()

  • Depth: 68 Millimeter
  • Width: 585 Millimeter
CTBKT2

  • Microwave ablation system generator
NEUWAVE AC System - 120V
NEUWAVE MEDICAL, INC.
2.45 GHz Ablation System
Not in Commercial Distribution

  • 00853719006180 ()
DR-000783

  • Microwave ablation system generator
ELECTROSURGICAL DEVICE WITHOUT ULTRASOUND MEANT FOR ELECTROCOAGULATION AND HEMOSTASIS IN DERMATOLOGIC SURGEY
Aesthetics Biomedical, Inc.
VERSION 1.0
Not in Commercial Distribution

  • G055ABMVIVS020 ()
ABMVIVS02

  • Intradermal radio-frequency ablation system
ELECTROSURGICAL DEVICE WITH OR WITHOUT ULTRASOUND MEANT FOR ELECTROCOAGULATION AND HEMOSTASIS IN DERMATOLOGIC SURGEY
Aesthetics Biomedical, Inc.
VERSION 1.0
In Commercial Distribution

  • G055ABMVIVS010 ()
ABMVIVS01

  • Intradermal radio-frequency ablation system
RADIOFREQUENCY APPLICATOR, INTERFACE BETWEEN CART AND MICRONEEDLE CARTRIDGE
Aesthetics Biomedical, Inc.
VERSION 1.0
In Commercial Distribution

  • G055ABMVIVR010 ()
ABMVIVR01

  • Intradermal radio-frequency ablation system
Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
INDIBA SA.
ACC1018USA
In Commercial Distribution

  • 08434251002667 ()
REVERSO applicator handle

  • Intradermal radio-frequency ablation system
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories.
INDIBA SA.
IDC0400USA
In Commercial Distribution

  • 08434251002636 ()
REVERSO

  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
FRX-C2
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR-C1
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR-C1
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR-C1
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR-AC-25
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR3.0
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR3.0
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR-C1
In Commercial Distribution



  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MTR-C1
In Commercial Distribution

  • 08800016903287 ()


  • Intradermal radio-frequency ablation system
CT Bed Rail Mount, Flat
NEUWAVE MEDICAL, INC.
DR-001446
In Commercial Distribution

  • 00818913020677 ()

  • Depth: 88 Millimeter
  • Width: 645 Millimeter
CTBKT5

  • Microwave ablation system generator
No Description
AGNES MEDICAL CO., LTD.
AGNES-S
In Commercial Distribution

  • 08800067700019 ()


  • Intradermal radio-frequency ablation system
No Description
AGNES MEDICAL CO., LTD.
AGNES
In Commercial Distribution

  • 08800067700002 ()


  • Intradermal radio-frequency ablation system
This is 1 set with following device AGNES-S: 1EA GA-B: 10EA, GA-C: 10EA, GA-E: 10EA, GA-F1A: 10EA, GA-F1B: 10EA, GA-I: 10EA GA-IL: 10EA, GA-S: 10EA, GA-SL: 10EA, GA-W3A: 10EA, GA-F3A: 10EA, GA-W3B: 10EA AG-CN18G: 10EA, AG-CN19G: 10EA, AG-CN20G: 10EA, AG-CN21G: 10EA, AG-CN23G: 10EA
AGNES MEDICAL CO., LTD.
AGNES-S
In Commercial Distribution

  • 18800067700016 ()


  • Intradermal radio-frequency ablation system
This is 1 set with following device AGNES: 1EA, GA-B: 10EA, GA-C: 10EA, GA-E: 10EA, GA-F1A: 10EA, GA-F1B: 10EA, GA-I: 10EA, GA-IL: 10EA, GA-S: 10EA, GA-SL: 10EA GA-W3A: 10EA, GA-F3A: 10EA, GA-W3B: 10EA AG-CN18G: 10EA, AG-CN19G: 10EA, AG-CN20G: 10EA, AG-CN21G: 10EA, AG-CN23G: 10EA
AGNES MEDICAL CO., LTD.
AGNES
In Commercial Distribution

  • 18800067700009 ()


  • Intradermal radio-frequency ablation system
Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.
INDIBA SA.
ACC1013
In Commercial Distribution

  • 18434251002831 ()
REVERSO tip 44 pins

  • Intradermal radio-frequency ablation system
Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.
INDIBA SA.
ACC1017
In Commercial Distribution

  • 18434251002725 ()
REVERSO tip 176 pins

  • Intradermal radio-frequency ablation system
Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.
INDIBA SA.
ACC1015
In Commercial Distribution

  • 18434251002718 ()
REVERSO tip 88 pins

  • Intradermal radio-frequency ablation system
Radiofrequency devices. Accessory intended to spread the electric current evenly though a needle array into the target area to be treated in a functional manner.
INDIBA SA.
ACC1016USA
In Commercial Distribution

  • 18434251002657 ()
REVERSO tip 160 pins

  • Intradermal radio-frequency ablation system
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