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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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Media Writer - 00850677007129

Media Writer Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007129 ()


  • Radiology DICOM image processing application software

Gearview QC - 00850677007051

Gearview QC Software
HYLAND LLC
2
In Commercial Distribution

  • 00850677007051 ()


  • Radiological PACS software

PACS Scan - 00850677007006

PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner

PoSAS - 00851113007758

PoSAS Desktop Software
ADVANCED BRAIN MONITORING, INC.
PS34-5401
In Commercial Distribution

  • 00851113007758 ()


  • Medical equipment clinical data interfacing software

Protura - 00841439102930

Protura Software Manual
MEDTEC, INC.
MT6XSM1.6.0
Not in Commercial Distribution

  • 00841439102930 ()

  • Width: 8.5 Inch
  • Length: 11 Inch
MT6XSM1.6.0

  • Indexed-immobilization patient positioning system

ILLUMISITE - 10884521779983

Procedure Software V1.0
Covidien LP
Procedure Application V1.0
In Commercial Distribution

  • 10884521779983 ()


  • Electromagnetic surgical navigation device tracking system

superDimension - 10884521747432

v7.1 Planning Software
Covidien LP
PMB00569-01
In Commercial Distribution

  • 10884521747432 ()


  • Electromagnetic surgical navigation device tracking system

ILLUMISITE - 10884521779990

Planning Software V1.0
Covidien LP
Planning Application V1.0
In Commercial Distribution

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking system

superDimension - 10884521747425

v7.2 Procedure Software
Covidien LP
PMB00667-01
In Commercial Distribution

  • 10884521747425 ()


  • Electromagnetic surgical navigation device tracking system

AESCULAP - 04038653423316

ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software

ARIAL - 00840948102769

Arial 11 Software
Securitas Healthcare LLC
54305
In Commercial Distribution

  • 00840948102769 ()
54305

  • Fixed call button

Arial U - 00840948101021

Arial U Software
Securitas Healthcare LLC
56112
In Commercial Distribution

  • 00840948101021 ()


  • Medical networking interface unit

not applicable - 00840682146845

Software Pristina Infinity
GE MEDICAL SYSTEMS
PRISTINA 2.0
In Commercial Distribution

  • 00840682146845 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

AESCULAP - 04046955206810

SOFTWARE MODULE DICOM
Aesculap AG
PV024
In Commercial Distribution

  • 04046955206810 ()
PV024

  • Neurosurgical microscope

Sentinel - 10841522125751

SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software

sterEOS® - 03663999000054

sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000030

sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software

Dexcom Clarity - 00038270000451

Data Manager Software
Dexcom, Inc.
350-0011
Not in Commercial Distribution

  • 00038270000451 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Smart-V-Link - 00894912002777

Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software

PAUS - 00894912002067

Modality Worklist Software
KOVEN TECHNOLOGY, INC.
2.0
In Commercial Distribution

  • 00894912002067 ()
PAUS2.0

  • Radiology information system application software

DRGEM - 08800011170004

Digital Imaging Software
DRGEM Corporation
RADMAX
In Commercial Distribution

  • 08800011170004 ()


  • Basic diagnostic x-ray system application software

CAD/CAM Software - E27666207800

Connect 4.5.0 Software
SIRONA Dental Systems GmbH
6620780
In Commercial Distribution

  • E27666207800 ()


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

CAD/CAM Software - E27666130090

CEREC 4.4.4 Software
SIRONA Dental Systems GmbH
6613009
In Commercial Distribution

  • E27666130090 ()


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

CAD/CAM Software - E27666104680

Connect 4.4.4 Software
SIRONA Dental Systems GmbH
6610468
In Commercial Distribution

  • E27666104680 ()


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

CAD/CAM Software - E27666104500

CEREC 4.5.0 Software
SIRONA Dental Systems GmbH
6610450
In Commercial Distribution

  • E27666104500 ()


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

CAD/CAM Software - E27666104270

inLab 16.0 Software
SIRONA Dental Systems GmbH
6610427
In Commercial Distribution

  • E27666104270 ()


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

Vmax - 10846446032925

VMAX SOFTWARE UPGRADE
Carefusion Corporation
28528-001
Not in Commercial Distribution

  • 10846446032925 ()
28528-001

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

IEM GmbH - 04041346102054

Hypertension Management Software
IEM GmbH
HMS CS 6.1.3 Medtronic 1.0.0
In Commercial Distribution

  • 04041346102054 ()


  • Medical equipment clinical data interfacing software

RMS - 08031527021188

Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software

CRW® - 10381780252610

StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system

UbiqVue - B353UA2550BG1

Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution

  • B353UA2550BG1 ()


  • Physiological measuring device wireless data capture/transfer unit

UbiqVue - B353UA2550S1

Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution

  • B353UA2550S1 ()


  • Network server

UbiqVue - B353UA2550RB1

Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution

  • B353UA2550RB1 ()


  • Physiological measuring device wireless data capture/transfer unit

SleepImage - B315SLEEPIMAGECOM0

Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier

DCTclock - B626100410

DCTclock Uploader Software
Linus Health, Inc.
10041
In Commercial Distribution

  • B626100410 ()
10041

  • Drawing-test cognitive function analysis device

Polaroid DDS - 10667147001542

Polaroid DDS software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001542 ()
PDDS

  • Radiology information system application software

XDR - D787XDRSW300

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software

XDR - D787XDRSW1

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software

ELI Edit - 00817655022802

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system

ELI Edit - 00817655022796

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system
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