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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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Radiochromic.com - B9875X10

Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.1
In Commercial Distribution

  • B9875X10 ()


  • Accelerator system quality assurance device

Radiochromic.com - B9875X00

Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.0
Not in Commercial Distribution

  • B9875X00 ()


  • Accelerator system quality assurance device

Radiochromic.com - B9874X00

Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
4.0
Not in Commercial Distribution

  • B9874X00 ()


  • Accelerator system quality assurance device

Radiochromic.com - B9873X40

Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.4
Not in Commercial Distribution

  • B9873X40 ()


  • Accelerator system quality assurance device

Radiochromic.com - B9873X30

Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.3
Not in Commercial Distribution

  • B9873X30 ()


  • Accelerator system quality assurance device

FONA CDR DICOM - D764B10351060

FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
SIRONA DENTAL, INC.
B1035106
In Commercial Distribution

  • D764B10351060 ()


  • Diagnostic x-ray digital imaging system workstation application software

GoCheck Kids - B430GCKNOK44360

GoCheck Kids stand-alone software for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.36
In Commercial Distribution

  • B430GCKNOK44360 ()


  • External ocular measurement camera

AHI System - B823AHIV200

The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution

  • B823AHIV200 ()


  • Clinical management support software

Analytic for Hemodynamic Instability - B823AHIP100

Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Fifth Eye, Inc.
P1
In Commercial Distribution

  • B823AHIP100 ()


  • Clinical management support software

NxStage Dosing Calculator - M535NX1272

No Description
NXSTAGE MEDICAL, INC.
NX1272
Not in Commercial Distribution

  • M535NX1272 ()


  • Clinical management support software
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