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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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Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system
Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114111 ()


  • General-purpose ultrasound imaging system
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838109957 ()
867019

  • Bedside information system application software
Software Revision 15.5
Philips Ultrasound LLC
989606720441
In Commercial Distribution

  • 00884838103603 ()


  • Radiological PACS software
PCH100 STANDALONE SOFTWARE
WELCH ALLYN, INC.
901052
In Commercial Distribution

  • 00732094128482 ()
704525

  • Electrocardiograph, professional, multichannel
SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system
Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system
DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software
vW CoFactor Software
CHRONO-LOG CORP
vW CoFactor Software
In Commercial Distribution

  • 00811476011045 ()


  • Platelet aggregation analyser IVD
AGGRO/LINK8 Software
CHRONO-LOG CORP
AGGRO/LINK8 Software
In Commercial Distribution

  • 00811476011021 ()


  • Platelet aggregation analyser IVD
Software ELI LINK
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094312812 ()
107347

  • Electrocardiograph, professional, multichannel
SOFTWARE HSCRIBE v6.2.0
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094281330 ()
11110-003-50

  • Electrocardiographic long-term ambulatory recording analyser application software
Q-STRESS SOFTWARE V4.60
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272352 ()
11090-001-50

  • Electrocardiographic lead set, reusable
Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774953
In Commercial Distribution

  • 15099590512453 ()
774953

  • Laboratory instrument/analyser application software IVD
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774951
In Commercial Distribution

  • 15099590512125 ()
774951

  • Laboratory instrument/analyser application software IVD
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774952
In Commercial Distribution

  • 15099590512118 ()
774952

  • Laboratory instrument/analyser application software IVD
Navios tetra Software
BECKMAN COULTER IRELAND INC.
775213
In Commercial Distribution

  • 15099590510756 ()
775213

  • Laboratory instrument/analyser application software IVD
Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution

  • 07540180000221 ()


  • Ultrasound patient positioning system
Planning Software V1.0
Covidien LP
Planning Application V1.0
In Commercial Distribution

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking system
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