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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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ESO accessory kit, PWS
Given Imaging, Inc.
FGS-8007
In Commercial Distribution

  • 07290101365426 ()


  • Manometric gastrointestinal motility analysis system
PDU, holding plate & top case mount
Given Imaging, Inc.
150110
In Commercial Distribution

  • 07290101365402 ()


  • Manometric gastrointestinal motility analysis system
PDU, cal chamber mounting kit
Given Imaging, Inc.
FGS-8014
In Commercial Distribution

  • 07290101365396 ()


  • Manometric gastrointestinal motility analysis system
V A400 Module
Given Imaging, Inc.
4439
In Commercial Distribution

  • 07290101364290 ()


  • Manometric gastrointestinal motility analysis system
ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution

  • 07290101364009 ()


  • Manometric gastrointestinal motility analysis system
The VUZE System (the “System”) enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device guidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7. The user of the VUZE System is a surgeon with the required qualifications for performing applicable spine surgeries. The System offers pre-operative surgical planning, including implant screw sizing and trajectory determination, as well as intra-operative assistance along the insertion of typical surgical tools (including tools used for placing implants) relative to rigid spinal structures.
VUZE MEDICAL LTD
VM-PK-001
In Commercial Distribution

  • 07290019776000 ()
  • 07290019776017 ()
VM-PK-001

  • Diagnostic x-ray digital imaging system workstation
No Description
BARDY DIAGNOSTICS, INC.
B1000R7000
In Commercial Distribution

  • 20851398007010 ()


  • Electrocardiographic ambulatory recorder
LessRay Assembly Transformer Mount
Nuvasive, Inc.
8230029
In Commercial Distribution

  • 00887517837363 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Table Clamp, Short
Nuvasive, Inc.
8230023
In Commercial Distribution

  • 00887517811936 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay IR Camera and Clamp
Nuvasive, Inc.
8230020
In Commercial Distribution

  • 00887517764133 ()


  • Diagnostic x-ray digital imaging system workstation
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