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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Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue.
INSIGHTEC LTD
4000 Type 1.1
In Commercial Distribution

  • 07290019402558 ()
SYS004000-CA

  • Ultrasonic hyperthermia system
OBALON® Navigation Console - component to visualize the OBALON® Balloon
Reshape Lifesciences Inc.
7402-0001
Not in Commercial Distribution

  • 00859810006180 ()


  • Gastrointestinal catheter/endoscope tracking system
LE Charging System
ST. JUDE MEDICAL, INC.
6722
In Commercial Distribution

  • 05414734405591 ()
6722

  • Noninvasive device battery charger
Powerheart® G5 Semi Automatic AED no battery or pads
Zoll Medical Corporation
G5S-19P0
In Commercial Distribution

  • 00812394023141 ()
G5S-19P0

  • Non-rechargeable public semi-automated external defibrillator
Powerheart® G5 Automatic AED no battery or pads
Zoll Medical Corporation
G5A-19P0
In Commercial Distribution

  • 00812394023134 ()
G5A-19P0

  • Non-rechargeable public automated external defibrillator
Powerheart G5 AED, Fully Automatic, Korean-International English, with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5A-19C
In Commercial Distribution

  • 00812394023103 ()
G5A-19C

  • Non-rechargeable public automated external defibrillator
Powerheart G5 AED, Semi Automatic, Korean- International English, with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5S-19C
In Commercial Distribution

  • 00812394023097 ()
G5S-19C

  • Non-rechargeable public semi-automated external defibrillator
Powerheart G5 AED, Semi Automatic, Korean-International English, with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5S-19A
In Commercial Distribution

  • 00812394022779 ()
G5S-19A

  • Non-rechargeable public semi-automated external defibrillator
Powerheart G5 AED, Fully Automatic, Korean-International English, with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5A-19A
In Commercial Distribution

  • 00812394022243 ()
G5A-19A

  • Non-rechargeable public automated external defibrillator
Powerheart® G5 AED, Semi-Automatic (US English / LA Spanish) with Intellisense Adult Electrodes with CPR Device and TSO Battery
Zoll Medical Corporation
G5S-80C-TSO
In Commercial Distribution

  • 00812394021420 ()
G5S-80C-TSO

  • Non-rechargeable public semi-automated external defibrillator
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