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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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Nitrile Examination Gloves
TEC GLOVES USA, LLC
X Large
In Commercial Distribution

  • 00860009233577 ()
  • 00860009233539 ()
TC21NXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000315 ()


  • Radiation therapy software
Steth IO - The Smartphone Stethoscope for iPhone X
Steth IO
iPhone X
In Commercial Distribution

  • 00860135001934 ()


  • Electronic acoustic stethoscope
A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000308 ()


  • Radiology DICOM image processing application software
No Description
SCIMAGE, INC
3.x
In Commercial Distribution

  • 00861917000305 ()


  • Radiological PACS software
No Description
Sysmex America, Inc.
1.X
In Commercial Distribution

  • 00664369000851 ()


  • Clinical laboratory information system application software
No Description
Sysmex America, Inc.
5.X
In Commercial Distribution

  • 00664369000752 ()


  • Clinical laboratory information system
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software
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