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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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Change Healthcare Cardiology - 17540262090055

No Description
Change Healthcare Canada Company
14.3.2
In Commercial Distribution

  • 17540262090055 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090048

No Description
Change Healthcare Canada Company
14.3
In Commercial Distribution

  • 17540262090048 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090031

No Description
Change Healthcare Canada Company
14.2
In Commercial Distribution

  • 17540262090031 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090024

No Description
CHANGE HEALTHCARE ISRAEL LTD
14.1.1
In Commercial Distribution

  • 17540262090024 ()


  • Cardiology information system

Change Healthcare Cardiology - 17540262090017

No Description
CHANGE HEALTHCARE ISRAEL LTD
14.1
In Commercial Distribution

  • 17540262090017 ()


  • Cardiology information system

Beacon - 06970027821084

8MP Color LCD Display
Shenzhen Beacon Display Technology Co., Ltd.
PA27
In Commercial Distribution

  • 06970027821084 ()


  • Pathology information system

Beacon - 06970027821077

8MP Color LCD Display
Shenzhen Beacon Display Technology Co., Ltd.
PA27T
In Commercial Distribution

  • 06970027821077 ()


  • Pathology information system

Beacon - 06970027820940

8MP Color LCD Display
Shenzhen Beacon Display Technology Co., Ltd.
C811WT
In Commercial Distribution

  • 06970027820940 ()


  • Pathology information system

Beacon - 06970027820902

8MP Color LCD Display
Shenzhen Beacon Display Technology Co., Ltd.
C811W
In Commercial Distribution

  • 06970027820902 ()


  • Pathology information system

Clear Guide SCENERGY TP - B201CGSCENERGYTP0

The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR. The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
CLEAR GUIDE MEDICAL, INC.
CGSCENERGYTP
In Commercial Distribution

  • B201CGSCENERGYTP0 ()
  • B201CGSCENERGYTP1 ()
CG-SCENERGY-TP

  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software
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