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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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Vital Sync - 10884521806740

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521806740 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521795273

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521795273 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521780668

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521780668 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521762619

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521762619 ()


  • Multiparameter physiologic analysis workstation

Holter Analysis Software Apnea - M582NEMK1270

Holter Analysis Software Apnea
Northeast Monitoring, Inc.
Holter Analysis Software Apnea
In Commercial Distribution

  • M582NEMK1270 ()
M582NEMK127

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1630

Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1610

Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system

Holter Analysis Software - M581NEMK1600

Holter Analysis Software Basic
Northeast Monitoring, Inc.
Basic
In Commercial Distribution

  • M581NEMK1600 ()
NEMK160

  • Cardiac arrhythmia monitoring system

DYONICS POWER - 03596010622716

DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered

N/A - 03596010588371

INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software

INTEGRATION BROKER - 03596010589637

SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software

CAD/CAM Software - E27667648770

Connect Software Version 5.2
SIRONA Dental Systems GmbH
6764877
In Commercial Distribution

  • E27667648770 ()


  • CAD/CAM software

CAD/CAM Software - E27667333360

OraCheck Software Version 5.0.0
SIRONA Dental Systems GmbH
6733336
In Commercial Distribution

  • E27667333360 ()


  • CAD/CAM software

CAD/CAM Software - E27667288150

Connect Software Version 5.1.0
SIRONA Dental Systems GmbH
6728815
In Commercial Distribution

  • E27667288150 ()


  • CAD/CAM software

CAD/CAM Software - E27667161740

CEREC Software Version 5.1.0
SIRONA Dental Systems GmbH
6716174
In Commercial Distribution

  • E27667161740 ()


  • CAD/CAM software

CAD/CAM Software - E27666868310

Connect Software Version 5.0.0
SIRONA Dental Systems GmbH
6686831
In Commercial Distribution

  • E27666868310 ()


  • CAD/CAM software

CAD/CAM Software - E27666822280

CEREC Software Version 5.0.0
SIRONA Dental Systems GmbH
6682228
In Commercial Distribution

  • E27666822280 ()


  • CAD/CAM software

CAD/CAM Software - E27666667180

Connect Software Version 4.6.0
SIRONA Dental Systems GmbH
6666718
In Commercial Distribution

  • E27666667180 ()


  • CAD/CAM software

CAD/CAM Software - E27666600670

CEREC Software Version 4.6.0
SIRONA Dental Systems GmbH
6660067
In Commercial Distribution

  • E27666600670 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software - E27666129850

CEREC Premium 4.4.4 Software
SIRONA Dental Systems GmbH
6612985
In Commercial Distribution

  • E27666129850 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software - E27666104350

CEREC Premium 4.5.0 Software
SIRONA Dental Systems GmbH
6610435
In Commercial Distribution

  • E27666104350 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

CAD/CAM Software - E27666101610

inLab CAM 16.0 Software
SIRONA Dental Systems GmbH
6610161
In Commercial Distribution

  • E27666101610 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

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 - 10884521810334

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521810334 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521812208

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521812208 ()


  • Multiparameter physiologic analysis workstation

SpecialsLab - 00840682123587

SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

ComboLab - 00840682123570

SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Mac-Lab - 00840682123556

SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682123549

SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

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 - 10884521823372

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521823372 ()


  • Multiparameter physiologic analysis workstation
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