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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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a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
ASSOCIATES OF CAPE COD, INC.
0
In Commercial Distribution

  • 00862696000289 ()


  • Laboratory instrument/analyser application software IVD
3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution

  • 00860007402302 ()


  • Radiation therapy software
No Description
Virtual Vision Health
3.2.0
In Commercial Distribution

  • 00860010709795 ()
VV-021

  • Perimeter, automatic
No Description
Virtual Vision Health
3.1.0
In Commercial Distribution

  • 00860010709788 ()


  • Perimeter, automatic
No Description
Virtual Vision Health
3.0.0
In Commercial Distribution

  • 00860010709757 ()


  • Perimeter, automatic
No Description
Virtual Vision Health
2.7.0
In Commercial Distribution

  • 00860010709740 ()


  • Perimeter, automatic
Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution

  • 00858184006130 ()


  • Gait-enhancement electrical stimulation system, external
No Description
Synaptive Medical Inc
2.2
In Commercial Distribution

  • 00670082000627 ()
SYN-0867

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
2.1
In Commercial Distribution

  • 00670082000504 ()
SYN-0867

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.5
In Commercial Distribution

  • 00670082000375 ()
SYN-0027

  • Neurological stereotactic surgery system
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