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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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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
CEREC 4.4.4 Software
SIRONA Dental Systems GmbH
6613009
In Commercial Distribution

  • E27666130090 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Connect 4.4.4 Software
SIRONA Dental Systems GmbH
6610468
In Commercial Distribution

  • E27666104680 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC 4.5.0 Software
SIRONA Dental Systems GmbH
6610450
In Commercial Distribution

  • E27666104500 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
inLab 16.0 Software
SIRONA Dental Systems GmbH
6610427
In Commercial Distribution

  • E27666104270 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Digital Imaging Software
DRGEM Corporation
RADMAX
In Commercial Distribution

  • 08800011170004 ()


  • Basic diagnostic x-ray system application software
ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software
WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software
Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution

  • 04250892980249 ()
36-SWR1134

  • Pulmonary function analysis system, adult
Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 04250892904153 ()
36-SWR1134

  • Diagnostic spirometer, professional
Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution

  • 04250892901633 ()
36-SWR1134

  • Pulmonary function analysis system, adult
EMG Reader Software
NATUS NEUROLOGY INCORPORATED
828-069700
In Commercial Distribution

  • 00382830035002 ()


  • Electromyograph
Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software
ENDEAVOR SOFTWARE V7
NATUS NEUROLOGY INCORPORATED
482-649300
In Commercial Distribution

  • 00382830037990 ()


  • Electromyograph
SOFTWARE MODULE DICOM
Aesculap AG
PV024
In Commercial Distribution

  • 04046955206810 ()
PV024

  • Neurosurgical microscope
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
EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software
MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution

  • 07612334140258 ()
  • H679033120000 ()
  • 10886982260949 ()
03312000

  • External orthopaedic fixation frame calculation software
Arial 11 Software
Securitas Healthcare LLC
54305
In Commercial Distribution

  • 00840948102769 ()
54305

  • Fixed call button
Arial U Software
Securitas Healthcare LLC
56112
In Commercial Distribution

  • 00840948101021 ()


  • Medical networking interface unit
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
8.0
In Commercial Distribution

  • 00810106410845 ()
987957

  • Radiation therapy software
Sales Demo Software
Coopersurgical, Inc.
23485-SRD
In Commercial Distribution

  • 60888937013483 ()


  • Urodynamic measurement system
DENTAL IMAGING SOFTWARE
CARESTREAM DENTAL LLC
Dental Imaging Software
In Commercial Distribution

  • 60192155319570 ()
5319579

  • General-purpose dental x-ray system application software
v3.0 software kit
Given Imaging, Inc.
FGS-0571
In Commercial Distribution

  • 07290101365921 ()


  • Manometric gastrointestinal motility analysis system
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