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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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No Description
XORAN TECHNOLOGIES LLC
v.6
In Commercial Distribution

  • 00860290000384 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
VERATHON INC
QuickPrint
In Commercial Distribution

  • 00879123006134 ()
0900-1238

  • Ultrasound imaging system application software
No Description
VERATHON INC
ScanPoint®
In Commercial Distribution

  • 00879123006127 ()


  • Ultrasound imaging system application software
No Description
VERATHON INC
ScanPoint Local Client
In Commercial Distribution

  • 00879123004239 ()
0900-1009

  • Ultrasound imaging system application software
Graft sizer
Inion Oy
1
In Commercial Distribution

  • M224INS93419 ()
  • 06438408002830 ()
INS-9341

  • Ligament graft sizer, noninvasive
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution

  • 00860004785101 ()

  • Length: 155 Millimeter
  • Width: 65 Millimeter
  • Height: 206 Millimeter
FIRMM®

  • MRI system application software
TrackX device that consists of a non-sterile Snap component that mates with retro-reflective spheres to create a unique SNAP that enables physicians to more adequately utilize pins, such as the TrackX Hex Pins, as a Home Base.
TrackX Technology, LLC
TrackX HOME BASE VS SNAP
In Commercial Distribution

  • 00857088008943 ()
TX-3-4314

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX SE RETRACT-ADAPT 5L - MJF VS
In Commercial Distribution

  • 00857088008875 ()
TX-3-4300

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-6.5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX SE RETRACT-ADAPT 6.5L - MJF VS
Not in Commercial Distribution

  • 00857088008851 ()
TX-3-4273

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX AT INSERT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008820 ()
TX-3-4229

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV RETRACT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008813 ()
TX-3-4201

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep
In Commercial Distribution

  • 00857088008806 ()
610-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 1
In Commercial Distribution

  • 00857088008790 ()
303-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a MOD Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson MOD T-Handle
In Commercial Distribution

  • 00857088008783 ()
1005-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a 1/4" square-style quick-connect.
TrackX Technology, LLC
TrackX 1/4" Square T-Handle
In Commercial Distribution

  • 00857088008776 ()
1004-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
ASC PROCEDURE KIT 1
In Commercial Distribution

  • 00857088008769 ()
980-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson T-Handle
In Commercial Distribution

  • 00857088008752 ()
1003-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 2
In Commercial Distribution

  • 00857088008745 ()
304-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle.
TrackX Technology, LLC
ACUITY NEEDLE - 15 DIAMOND - 3.2 INNER
In Commercial Distribution

  • 00857088008738 ()
202-4TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT™ ARRAY-VIOLET when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ ARRAY-VIOLET
In Commercial Distribution

  • 00857088008714 ()
703-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable Pin instrument.
TrackX Technology, LLC
Hex Pin 6mm x 100mm
In Commercial Distribution

  • 00857088008707 ()
205-4TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - DS Disc Prep - MJF VS
In Commercial Distribution

  • 00857088008691 ()
TX-3-4182

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX-25 SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX PE ADAPT - MJF VS
In Commercial Distribution

  • 00857088008677 ()
TX-3-4121

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV INSERT-ADAPT
In Commercial Distribution

  • 00857088008660 ()
TX-3-4089

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep - MJF VS
In Commercial Distribution

  • 00857088008653 ()
TX-3-4079

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep - MJF
Not in Commercial Distribution

  • 00857088008646 ()
TX-3-4166

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable Pin instrument.
TrackX Technology, LLC
Hex Pin 6mm x 150mm
In Commercial Distribution

  • 00857088008622 ()
206-4TX

  • Diagnostic x-ray digital imaging system workstation application software
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