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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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DCTclock Uploader Software
Linus Health, Inc.
10041
In Commercial Distribution

  • B626100410 ()
10041

  • Drawing-test cognitive function analysis device
Polaroid DDS software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001542 ()
PDDS

  • Radiology information system application software
SOFTWARE MODULE DICOM
Aesculap AG
PV024
In Commercial Distribution

  • 04046955206810 ()
PV024

  • Neurosurgical microscope
ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software
Software Pristina Infinity
GE MEDICAL SYSTEMS
PRISTINA 2.0
In Commercial Distribution

  • 00840682146845 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
Hypertension Management Software
IEM GmbH
HMS CS 6.1.3 Medtronic 1.0.0
In Commercial Distribution

  • 04041346102054 ()


  • Medical equipment clinical data interfacing software
VMAX SOFTWARE UPGRADE
Carefusion Corporation
28528-001
Not in Commercial Distribution

  • 10846446032925 ()
28528-001

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
Data Manager Software
Dexcom, Inc.
350-0011
Not in Commercial Distribution

  • 00038270000451 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system
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