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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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Invivo - 00884838081550

UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software

N/A - 00885074445465

SOFTWARE, 9732430, SPINE UNIFIED
MEDTRONIC NAVIGATION, INC.
9732430
In Commercial Distribution

  • 00885074445465 ()


  • Multi-purpose stereotactic surgery system

Software LENS Tablet Application - 00885556653876

SOFTWARE LENS TABLET APPLICATION
Smith & Nephew, Inc.
72204699
In Commercial Distribution

  • 00885556653876 ()
72204699

  • Endoscopic video imaging system

Affiniti 70C Diagnostic Ultrasound System - 00884838114470

Software Version 6.X
Philips Ultrasound LLC
795186
In Commercial Distribution

  • 00884838114470 ()


  • General-purpose ultrasound imaging system

Affiniti 70 Diagnostic Ultrasound System - 00884838114456

Software Version 6.X
Philips Ultrasound LLC
795187
In Commercial Distribution

  • 00884838114456 ()


  • General-purpose ultrasound imaging system

Affiniti 30 Diagnostic Ultrasound System - 00884838114197

Software version - 10.0.X
Philips Ultrasound LLC
795218
In Commercial Distribution

  • 00884838114197 ()


  • General-purpose ultrasound imaging system

Affiniti 70 Diagnostic Ultrasound System - 00884838114180

Software version- 10.0.X
Philips Ultrasound LLC
795210
In Commercial Distribution

  • 00884838114180 ()


  • General-purpose ultrasound imaging system

Affiniti 50 Diagnostic Ultrasound System - 00884838114173

Software version - 10.0.X
Philips Ultrasound LLC
795208
In Commercial Distribution

  • 00884838114173 ()


  • General-purpose ultrasound imaging system

Affiniti CVx Diagnostic Ultrasound System - 00884838114166

Software version- 10.0.X
Philips Ultrasound LLC
795190
In Commercial Distribution

  • 00884838114166 ()


  • General-purpose ultrasound imaging system

EPIQ Elite Diagnostic Ultrasound System - 00884838114159

Software version- 10.0.X
Philips Ultrasound LLC
795234
In Commercial Distribution

  • 00884838114159 ()


  • General-purpose ultrasound imaging system

EPIQ CVxi Diagnostic Ultrasound System - 00884838114142

Software version 10.0.X
Philips Ultrasound LLC
795232
In Commercial Distribution

  • 00884838114142 ()


  • General-purpose ultrasound imaging system

EPIQ CVx Diagnostic Ultrasound System - 00884838114135

Software version 10.0.X
Philips Ultrasound LLC
795231
In Commercial Distribution

  • 00884838114135 ()


  • General-purpose ultrasound imaging system

EPIQ 7W Diagnostic Ultrasound System - 00884838114104

Software version - 10.0.x
Philips Ultrasound LLC
795202
In Commercial Distribution

  • 00884838114104 ()


  • General-purpose ultrasound imaging system

EPIQ 7 Diagnostic Ultrasound System - 00884838114098

Software version - 10.0.x
Philips Ultrasound LLC
795200
In Commercial Distribution

  • 00884838114098 ()


  • General-purpose ultrasound imaging system

EPIQ Elite Ultrasound Circular Edition - 00884838113961

Software Version 9.x
Philips Ultrasound LLC
795125
In Commercial Distribution

  • 00884838113961 ()


  • General-purpose ultrasound imaging system

Lumify Ultrasound Circular Edition - 00884838113947

Software version 4.X
Philips Ultrasound LLC
795123
In Commercial Distribution

  • 00884838113947 ()


  • General-purpose ultrasound imaging system

Lumify Ultrasound Circular Edition - 00884838113930

Software version 3.x
Philips Ultrasound LLC
795123
In Commercial Distribution

  • 00884838113930 ()


  • General-purpose ultrasound imaging system

EPIQ CVx Ultrasound Circular Edition - 00884838113923

Software Version 9.x
Philips Ultrasound LLC
795122
In Commercial Distribution

  • 00884838113923 ()


  • General-purpose ultrasound imaging system

EPIQ CVx Ultrasound Circular Edition - 00884838113916

Software version 7.x
Philips Ultrasound LLC
795122
In Commercial Distribution

  • 00884838113916 ()


  • General-purpose ultrasound imaging system

Affiniti 30 Ultrasound Circular Edition - 00884838113909

Software version 9.X
Philips Ultrasound LLC
795121
In Commercial Distribution

  • 00884838113909 ()


  • General-purpose ultrasound imaging system

EPIQ 5 Ultrasound Circular Edition - 00884838113886

Software Version 9.X
Philips Ultrasound LLC
795120
In Commercial Distribution

  • 00884838113886 ()


  • General-purpose ultrasound imaging system

Sparq Ultrasound Circular Edition - 00884838113794

Software version 2.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113794 ()


  • General-purpose ultrasound imaging system

CX50 Ultrasound Circular Edition - 00884838113787

Software version 5.X
Philips Ultrasound LLC
795114
In Commercial Distribution

  • 00884838113787 ()


  • General-purpose ultrasound imaging system

EPIQ Elite W Diagnostic Ultrasound System - 00884838111004

Software version 6.X
Philips Ultrasound LLC
795258
In Commercial Distribution

  • 00884838111004 ()


  • General-purpose ultrasound imaging system

Affiniti 70W Diagnostic Ultrasound System - 00884838114463

Software Version 6.X
Philips Ultrasound LLC
795185
In Commercial Distribution

  • 00884838114463 ()


  • General-purpose ultrasound imaging system

Affiniti 30 Ultrasound Circular Edition - 00884838113893

Software version 7.x
Philips Ultrasound LLC
795121
In Commercial Distribution

  • 00884838113893 ()


  • General-purpose ultrasound imaging system

Affiniti 70 Ultrasound Circular Edition - 00884838113862

Software version 9.X
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113862 ()


  • General-purpose ultrasound imaging system

Affiniti 70 Ultrasound Circular Edition - 00884838113855

Software version 7.x
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113855 ()


  • General-purpose ultrasound imaging system

Affiniti 50 Ultrasound Circular Edition - 00884838113831

Software Version 7.X
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838113831 ()


  • General-purpose ultrasound imaging system

EPIQ 7 Ultrasound Circular Edition - 00884838113824

Software Version 9.X
Philips Ultrasound LLC
795117
In Commercial Distribution

  • 00884838113824 ()


  • General-purpose ultrasound imaging system

Sparq Ultrasound Circular Edition - 00884838113800

Software version 3.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113800 ()


  • General-purpose ultrasound imaging system

PULSE - 00195377065506

PULSE Software, Base Image
Nuvasive, Inc.
1802489
In Commercial Distribution

  • 00195377065506 ()


  • Orthopaedic stereotactic surgery system

MUSE - 00195278458070

MUSE NX R2 SOFTWARE
Ge Medical Systems Information Technologies, Inc.
NX R2
In Commercial Distribution

  • 00195278458070 ()
4101010-002

  • Cardiology information system application software

N/A - 04961333236589

COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device

Vital Sync - 10884521854260

VITAL SYNC V4 SOFTWARE
Covidien LP
VITALSYNCSW04
In Commercial Distribution

  • 10884521854260 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521849358

VITAL SYNC V4 SOFTWARE
Covidien LP
VITALSYNCSW04
In Commercial Distribution

  • 10884521849358 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521847675

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521847675 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521847569

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521847569 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521845176

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521845176 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521844940

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521844940 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521844933

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521844933 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521835962

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521835962 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521835870

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521835870 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521829855

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521829855 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521829848

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521829848 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521823372

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521823372 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521818965

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521818965 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521812208

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521812208 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521810334

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521810334 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521806740

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521806740 ()


  • Multiparameter physiologic analysis workstation
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