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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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NOVA 5 Na+, K+, Cl-, HCt CALIBRATOR
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 00385480156486 ()
15648

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software
TIDI Positioning Aid Kits Kit, Various Sizes 8 per Set
TIDI PRODUCTS, LLC
5
Not in Commercial Distribution

  • 00618125168217 ()


  • Multifunction body cushion
Uni Tibial Tray Size 5
SIGNAL MEDICAL CORPORATION
5
In Commercial Distribution

  • B046WZ110150 ()
WZ-1-1015

  • Coated unicondylar knee tibia prosthesis
Uni Femoral Knee Size 5
SIGNAL MEDICAL CORPORATION
5
In Commercial Distribution

  • B046WZ110050 ()
WZ-1-1005

  • Coated knee femur prosthesis
Cutaneous Electrode Garment Released as revision 5 on 2017-11-28
AXIOBIONICS
5
In Commercial Distribution

  • B3673350 ()
  • B3673340 ()
33

  • Transcutaneous electrical stimulation electrode, single-use
No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
No Description
Fivos, Inc.
5
Not in Commercial Distribution

  • B159FIVOSPACS0 ()


  • Radiological PACS software
No Description
Mobilehelp, LLC
5
In Commercial Distribution

  • 00817644020079 ()


  • Home healthcare information system application software
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