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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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Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-51    
In Commercial Distribution

  • 00817655020259 ()


  • Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-50    
In Commercial Distribution

  • 00817655020242 ()


  • Cardiology information system application software
Data Manager Software
Dexcom, Inc.
350-0011
Not in Commercial Distribution

  • 00038270000451 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DCTclock Uploader Software
Linus Health, Inc.
10041
In Commercial Distribution

  • B626100410 ()
10041

  • Drawing-test cognitive function analysis device
VMAX SOFTWARE UPGRADE
Carefusion Corporation
28528-001
Not in Commercial Distribution

  • 10846446032925 ()
28528-001

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
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
sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software
Connect 4.5.0 Software
SIRONA Dental Systems GmbH
6620780
In Commercial Distribution

  • E27666207800 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
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