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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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Pure Vue - 10886705032204

Pure Vue Software expansion
Medos International Sàrl
242329
In Commercial Distribution

  • 10886705032204 ()
242329

  • Software upgrade/unlocking key

BLUE LIGHT IMAGING UNIT - 04953170396021

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2305
In Commercial Distribution

  • 04953170396021 ()
N5769640

  • Software upgrade/unlocking key

Infrared imaging unit - 04953170395994

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
In Commercial Distribution

  • 04953170395994 ()


  • Software upgrade/unlocking key

AUTO FOCUS UNIT - 04953170395963

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2303
In Commercial Distribution

  • 04953170395963 ()


  • Software upgrade/unlocking key

OTV-S500 UPGRADE PACK STROBE - 04953170458170

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key

OTV-S700 UPGRADE PACK 3D - 04953170445453

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2511
In Commercial Distribution

  • 04953170445453 ()
N6189440

  • Software upgrade/unlocking key

SWQ SOFTWARE OPTION - 04953170431906

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2383
In Commercial Distribution

  • 04953170431906 ()
N6157530

  • Software upgrade/unlocking key

ELST SOFTWARE OPTION - 04953170431890

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2382
In Commercial Distribution

  • 04953170431890 ()
N6157430

  • Software upgrade/unlocking key

CHE SOFTWARE OPTION - 04953170431883

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2381
In Commercial Distribution

  • 04953170431883 ()
N6157330

  • Software upgrade/unlocking key

Infrared imaging unit - 04953170424724

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
Not in Commercial Distribution

  • 04953170424724 ()


  • Software upgrade/unlocking key

UPGRADE KIT FOR UCES-3 (Version 4) - 04953170335464

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2051
Not in Commercial Distribution

  • 04953170335464 ()


  • Software upgrade/unlocking key

CHATTANOOGA - 00888912296533

CARD MULTIMEDIA DTS
DJO, LLC
2842
In Commercial Distribution

  • 00888912296533 ()


  • Software upgrade/unlocking key

Invivo - 00884838081550

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

  • 00884838081550 ()


  • Stereotactic system application software

Affiniti 70C Diagnostic Ultrasound System - 00884838114470

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

  • 00884838114470 ()


  • 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 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

Affiniti 30 Ultrasound Circular Edition - 00884838113893

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

  • 00884838113893 ()


  • 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

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

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

ECG Plug-In - 00852132007309

Monitor communication software application
PREVENTICE TECHNOLOGIES, INC.
SW1003
In Commercial Distribution

  • 00852132007309 ()


  • Cardiopulmonary physiological parameter analysis software

ClearPoint - 00850047354099

ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system

FrameLink™ - 00643169363540

SOFTWARE 9733986 FRAMELINK S7
MEDTRONIC NAVIGATION, INC.
9733986
In Commercial Distribution

  • 00643169363540 ()


  • Multi-purpose stereotactic surgery system

Respiratory Module - 05056190500733

Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system

StealthStation® Cranial - 00643169625532

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00643169625532 ()


  • Neurological stereotactic surgery system

N/A - 00643169491830

SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system

DENTCA Design - 00856551007506

DENTCA Design - DENTCA Software
DENTCA, INC.
DENTCA Design - Software
In Commercial Distribution

  • 00856551007506 ()


  • CAD/CAM software

OmniTour - 00858703006375

Therapy cycling feedback software
ACCELERATED CARE PLUS CORP
OmniTourSoftware
In Commercial Distribution

  • 00858703006375 ()


  • Bioelectrical signal analysis software

RIT - 00857450006003

Dosimetry and QA Software
RADIOLOGICAL IMAGING TECHNOLOGY
113
In Commercial Distribution

  • 00857450006003 ()
RIT113

  • Accelerator system quality assurance device
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