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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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RTgo - 00884838092112

MR-RT RTgo software USB stick
Philips Oy
459801266633
In Commercial Distribution

  • 00884838092112 ()


  • MRI system application software

m2000 - 00884999043503

m2000rt SYSTEM SOFTWARE Release 8.0
ABBOTT MOLECULAR INC.
08N89-001
In Commercial Distribution

  • 00884999043503 ()
08N89-001

  • Laboratory analyser operation system software IVD

m2000 - 00884999043497

m2000sp SYSTEM SOFTWARE, Release 8.0
ABBOTT MOLECULAR INC.
08N88-001
In Commercial Distribution

  • 00884999043497 ()
08N88-001

  • Laboratory instrument/analyser application software IVD

LUCAS Report Generator - 00883873851913

SOFTWARE EXECUTABLE, LUCAS Report Generator
PHYSIO-CONTROL, INC.
60600
In Commercial Distribution

  • 00883873851913 ()
60600-000145

  • Medical equipment clinical data interfacing software

NA - 00840682107990

MR Applications Software MP24 R01
GENERAL ELECTRIC COMPANY
MP24
Not in Commercial Distribution

  • 00840682107990 ()


  • Full-body MRI system, superconducting magnet
  • PET system

Welch Allyn, Inc. - 00817655021294

DVD SOFTWARE XScribe CP v4.0.3
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00817655021294 ()
420181

  • Electrocardiographic lead set, reusable

TREON® plus and TRIA® plus - 00721902849787

SOFTWARE 9730877 ORTHO LICENSE (PLUS)
MEDTRONIC NAVIGATION, INC.
9730877
Not in Commercial Distribution

  • 00721902849787 ()


  • Multi-purpose stereotactic surgery system

Welch Allyn, Inc. - 00732094250879

CONNEX CS SOFTWARE DELIVERY PHANTOM
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250879 ()
411066

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094212464

TAGCONNECT SOFTWARE AND SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094212464 ()
TAGECG-SW

  • Electrocardiographic ambulatory recorder

PillCam - 07290110360795

PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software

Vue RIS - 60889978671366

RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software

Welch Allyn, Inc. - 00732094319903

SOFTWARE SURVYOR CENTRAL REPEATER DVD
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094319903 ()
419832

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094315493

WADCS ECG SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315493 ()
729324

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094315486

WADCS SPIRO SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315486 ()
729325

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094315479

WADCS MANAGER SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315479 ()
729326

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094307375

Q-TEL V5.0.1 Q-PROGRESS SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307375 ()
419733

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307368

Q-TEL V5.0.1 Workstation Software CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307368 ()
413379

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307351

QTEL v5.0.1 TOWER SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307351 ()
419751

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094300710

ELI LINK V4.5.1 SOFTWARE DVD
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094300710 ()
413225

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094296341

SOFTWARE MONITIOR WAVEFORM VIEWER V2.1.0
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094296341 ()
11093-003-50

  • Cardiology information system application software

Welch Allyn, Inc. - 00732094272345

SOFTWARE ARRHYTHMIA ST LIBRARY v6.0.3
WELCH ALLYN, INC.
901008
In Commercial Distribution

  • 00732094272345 ()
11091-002-50

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094325300

DVD SOFTWARE RScribe Lite v1.0.2
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094325300 ()
419614

  • Electrocardiograph, professional, multichannel

Synergy®Cranial - 00763000253158

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00763000253158 ()


  • Multi-purpose stereotactic surgery system

CareLink™ - 00763000424138

PRODUCT SOFTWARE MMT-7350 PROWEB 3.13A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000424138 ()


  • Patient health record information system application software

moorFLPI-2 Clinical PC Software - 15060484490157

moorFLPI-2 Clinical PC Software V1
MOOR INSTRUMENTS LIMITED
1
Not in Commercial Distribution

  • 15060484490157 ()


  • Cutaneous microcirculation laser Doppler imaging device

moorFLPI2- Measurement PC Software - 15060484490126

moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490126 ()


  • Cutaneous microcirculation laser Doppler imaging device

moorFLPI-2 Review PC Software - 15060484490119

moorFLPI-2 Review PC Software V5
MOOR INSTRUMENTS LIMITED
5
In Commercial Distribution

  • 15060484490119 ()


  • Cutaneous microcirculation laser Doppler imaging device

Kaluza C - 15099590705169

Kaluza C Flow Cytometry Software
Beckman Coulter, Inc.
Flow Cytometry Software
In Commercial Distribution

  • 15099590705169 ()
C21166

  • Laboratory instrument/analyser application software IVD

CareLink™ Clinic - 00763000984762

PRODUCT SOFTWARE MMT-7350 PROWEB 4.1A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000984762 ()


  • Patient health record information system application software

Diversatek Healthcare - 00816734023488

Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Monarch™ Cart Software v4.1.1 - 10810068811503

Monarch™ Cart Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811503 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.1 - 10810068811497

Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software

Vital Sync - 10884521851559

VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521815810

Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Puritan Bennett - 10884521211551

IE Sync Trigger Software Update
Covidien LP
980IESYNC
In Commercial Distribution

  • 10884521211551 ()


  • Ventilator application software

AVEA - 10190752159075

KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software

Stealth System S300 - 00857553006092

StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
Not in Commercial Distribution

  • 00857553006092 ()
  • 00857553006061 ()
C300/D300

  • Electrocardiographic ambulatory recorder

Paradigm - 00850042604014

Paradigm System Cart, 120-volt
Proprio, Inc.
1100006
In Commercial Distribution

  • 00850042604014 ()
1100006

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Paradigm - 00850042604007

Paradigm System Cart
Proprio, Inc.
1100001
Not in Commercial Distribution

  • 00850042604007 ()
  • 10850042604004 ()
1100003

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Visix - 00851800007092

Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software

LATITUDE Consult™ - 00802526562907

LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562907 ()


  • Cardiac pulse generator software

LATITUDE Consult™ - 00802526562914

LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562914 ()


  • Cardiac pulse generator software

Vision RT - B120ALIGNRT0

No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system

IDENTIFY - EHUQHQ0100707

The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software

LUNA 3D - 04260590372659

No Description
L A P GMBH LASER APPLIKATIONEN
Central Server host PC Luna 3D
In Commercial Distribution

  • 04260590372659 ()
0018439-0001

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372642

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372642 ()
0018346-0003

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372635

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372635 ()
0018346-0002

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372628

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372628 ()
0018440

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372611

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372611 ()
0018438

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372604

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
Not in Commercial Distribution

  • 04260590372604 ()
0018914

  • Radiological video camera patient positioning/tracking system
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