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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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hi Health Innovations - 00858177007076

Hearing Aid Fitting Software
INTRICON CORPORATION
hi-PS
In Commercial Distribution

  • 00858177007076 ()
22724

  • Hearing aid wireless-fitting computer-aided set

Kinesia StimPoint - 00859584006195

Kinesia StimPoint Application Software
Great Lakes Neurotechnologies Inc.
360-0050 Kinesia StimPoint Software
In Commercial Distribution

  • 00859584006195 ()
360-0050

  • Tremor transducer

Kinesia 360 - 00859584006126

Kinesia 360, Application Software
Great Lakes Neurotechnologies Inc.
360-0041, Application Software
In Commercial Distribution

  • 00859584006126 ()


  • Tremor transducer

Kinesia One - 00859584006119

Kinesia One, Application Software
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution

  • 00859584006119 ()


  • Tremor transducer

AESCULAP - 04046963895853

ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software

AESCULAP - 04046963492083

ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software

AESCULAP - 04046963989101

ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software

AESCULAP - 04046963977979

ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software

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

Vital Sync - 10884521806740

VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521806740 ()


  • 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

AEOS - 04046955206803

SOFTWARE MODULE DIR 800
Aesculap AG
PV023
In Commercial Distribution

  • 04046955206803 ()
PV023

  • Surgical microscope fluorescent angiography system

AESCULAP - 04046955206797

SOFTWARE MODULE DUV 400
Aesculap AG
PV022
In Commercial Distribution

  • 04046955206797 ()
PV022

  • Neurosurgical microscope

KBA3D - 03701313007935

Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software

KBA3D - 03701313000479

Spinal surgery planning software
S.M.A.I.O
V1.1.X
Not in Commercial Distribution

  • 03701313000479 ()


  • Radiological PACS software

Holter Analysis Software - M581NEMK1630

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

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system

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 - 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

Centralized Configuration Manager Software - 10711234540121

Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory

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

Alaris - 10885403516054

Alaris EtCO2 V12.3 Software
CAREFUSION 303, INC.
8300
In Commercial Distribution

  • 10885403516054 ()


  • Carbon dioxide monitor

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
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