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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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PMD Viewer Software
Spencer Technologies
PMD Viewer
In Commercial Distribution

  • 00862726000326 ()
12143

  • Radiology DICOM image processing application software
Dosimetry QA Software
VARIAN MEDICAL SYSTEMS, INC.
6.8.0
Not in Commercial Distribution

  • 00861334000339 ()
DoseLab Pro

  • Accelerator system quality assurance device
WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software
Instrument selection software
Brainlab AG
1.5
In Commercial Distribution

  • 04056481142018 ()


  • Robotic surgical navigation system
Protura Software Manual
MEDTEC, INC.
MT6XSM1.6.0
Not in Commercial Distribution

  • 00841439102930 ()

  • Width: 8.5 Inch
  • Length: 11 Inch
MT6XSM1.6.0

  • Indexed-immobilization patient positioning system
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
Modality Worklist Software
KOVEN TECHNOLOGY, INC.
2.0
In Commercial Distribution

  • 00894912002067 ()
PAUS2.0

  • Radiology information system application software
Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software
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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