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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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ManoView - 07290101365778

v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution

  • 07290101365778 ()


  • Manometric gastrointestinal motility analysis system

Mano Scan - 07290101365754

ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution

  • 07290101365754 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101364009

ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution

  • 07290101364009 ()


  • Manometric gastrointestinal motility analysis system

SmartPill - 07290110360481

SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system

Reflux - 07290110360429

Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system

LATITUDE® Clarity - 00802526613838

Device Services Software
BOSTON SCIENTIFIC CORPORATION
7260
In Commercial Distribution

  • 00802526613838 ()
7260

  • Patient health record information system application software

Navios Analysis Software - 15099590512453

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774953
In Commercial Distribution

  • 15099590512453 ()
774953

  • Laboratory instrument/analyser application software IVD

Navios Analysis Software - 15099590512125

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774951
In Commercial Distribution

  • 15099590512125 ()
774951

  • Laboratory instrument/analyser application software IVD

Navios Analysis Software - 15099590512118

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774952
In Commercial Distribution

  • 15099590512118 ()
774952

  • Laboratory instrument/analyser application software IVD

Navios tetra Software - 15099590510756

Navios tetra Software
BECKMAN COULTER IRELAND INC.
775213
In Commercial Distribution

  • 15099590510756 ()
775213

  • Laboratory instrument/analyser application software IVD

Vyaire - 34250892904161

Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 34250892904161 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

MicroMedical - 34250892901603

Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution

  • 34250892901603 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Spirometry PC Software - 34250892980233

Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution

  • 34250892980233 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Dental Imaging Software - 60889975319575

DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software

MAXUM - M737M61021

Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system

Welch Allyn, Inc. - 00732094128482

PCH100 STANDALONE SOFTWARE
WELCH ALLYN, INC.
901052
In Commercial Distribution

  • 00732094128482 ()
704525

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094312812

Software ELI LINK
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094312812 ()
107347

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094281330

SOFTWARE HSCRIBE v6.2.0
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094281330 ()
11110-003-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272352

Q-STRESS SOFTWARE V4.60
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272352 ()
11090-001-50

  • Electrocardiographic lead set, reusable

QLAB Advanced Quantification Software - 00884838103603

Software Revision 15.5
Philips Ultrasound LLC
989606720441
In Commercial Distribution

  • 00884838103603 ()


  • Radiological PACS software

IntelliVue XDS Software - 00884838092099

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838092099 ()
867019

  • Bedside information system application software

IntelliVue XDS Software - 00884838059313

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838059313 ()
867019

  • Bedside information system application software

IntelliVue XDS Software - 00884838123175

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software - R
In Commercial Distribution

  • 00884838123175 ()
867019

  • Bedside information system application software

Affinti 70 Diaagnostic Ultrasound System Circular Edition - 00884838114258

Software Version 10.0.2
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838114258 ()


  • General-purpose ultrasound imaging system

Affinti 50 Diaagnostic Ultrasound System Circular Edition - 00884838114241

Software Version 10.0.2
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838114241 ()


  • General-purpose ultrasound imaging system

EPIQ 5 Diagnostic Ultrasound System - 00884838114111

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

  • 00884838114111 ()


  • General-purpose ultrasound imaging system

IntelliVue XDS Software - 00884838109957

IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838109957 ()
867019

  • Bedside information system application software

EPIQ 5W Diagnostic Ultrasound System - 00884838114128

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

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system

PULSE - 00195377065544

PULSE Software, v4.0.0-bln.eu
Nuvasive, Inc.
1802497
In Commercial Distribution

  • 00195377065544 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065537

PULSE Software, v4.0.0-bln.us
Nuvasive, Inc.
1802495
In Commercial Distribution

  • 00195377065537 ()


  • Orthopaedic stereotactic surgery system
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