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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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Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of the scope is less than or equal to 6.2 mm.
Suzhou AcuVu medical technology Co., Ltd.
HTx60
In Commercial Distribution

  • 26974880990028 ()
  • 06974880990024 ()


  • Rigid video hysteroscope
This is the control unit for the scopes. It stores images and videos on its hard drive. It allows users to modify settings such as white balance and zoom.
Suzhou AcuVu medical technology Co., Ltd.
HTx1000
In Commercial Distribution

  • 06974880990017 ()


  • Rigid video hysteroscope
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
No Description
GE Vingmed Ultrasound AS
E80 v203 with OLED
In Commercial Distribution

  • 00840682141550 ()


  • Cardiovascular ultrasound imaging system
No Description
GE Medical Systems (China) Co.,Ltd.
Premier VA
In Commercial Distribution

  • 00840682141178 ()


  • General-purpose ultrasound imaging system
No Description
GE Medical Systems (China) Co.,Ltd.
Premier VS
In Commercial Distribution

  • 00840682141147 ()


  • General-purpose ultrasound imaging system
No Description
GE Ultrasound Korea Ltd.
P6 BT18
In Commercial Distribution

  • 00840682138208 ()


  • General-purpose ultrasound imaging system
LE Charging System
ST. JUDE MEDICAL, INC.
6722
In Commercial Distribution

  • 05414734405591 ()
6722

  • Noninvasive device battery charger
Reusable Powered Handle
Covidien LP
IDRVULTRA1
Not in Commercial Distribution

  • 10884521142794 ()


  • Open-surgery manual linear stapler, reusable
The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62 kg and the sizes 47 x 56 x 106 cm (LxWxH) without external parts and reclined display and 47 x 56 x 202 cm (LxWxH) with handpiece holders at maximum extension Electrical requirements: 115V~, 50/60Hz, 2300VA. The operator interacts directly with the external portions of the system displayed in the following.
DEKA M.E.L.A. SRL
M135A1
In Commercial Distribution

  • 08034108512464 ()


  • Multi-modality skin surface treatment system
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