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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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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

Sentinel - 10841522125751

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

  • 10841522125751 ()
98201

  • Cardiology information system application software

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

CuattroDR - B269SWR00069MD0

CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

Spirometry PC Software - 34250892980233

Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution

  • 34250892980233 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Vyaire - 34250892904161

Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 34250892904161 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

MicroMedical - 34250892901603

Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution

  • 34250892901603 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Scopis ENT - 07613327413243

Scopis ENT Software
Stryker Leibinger GmbH & Co. KG
8000-020-001
In Commercial Distribution

  • 07613327413243 ()
8000-020-001

  • Stereotactic system application software

SpineMap Go - 07613327412994

SpineMap Go - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-690-000
In Commercial Distribution

  • 07613327412994 ()
6002-690-000

  • Surgical planning/navigation-enhancement system

Clarity® - 07540180000184

Clarity® Software
Elekta Ltd
9310-00042
In Commercial Distribution

  • 07540180000184 ()


  • Ultrasound patient positioning system

N/A - 07613327568998

QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter

N/A - 07613327545883

Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system

Cranial Guidance Software - 07613327538298

Cranial Guidance Software
Stryker Leibinger GmbH & Co. KG
6000-670-000
In Commercial Distribution

  • 07613327538298 ()
6000-670-000

  • Electromagnetic/optical surgical navigation device tracking system

SurgiCount - 07613327622751

+ Sponge Counting Software
STRYKER CORPORATION
0894000003
In Commercial Distribution

  • 07613327622751 ()
0894-000-003

  • Electronic surgical sponge-counter

PROFESS - 07613327071948

PROFESS(TM) SOFTWARE
Stryker Leibinger GmbH & Co. KG
6001-400-000
In Commercial Distribution

  • 07613327071948 ()
6001-400-000

  • Robotic surgical navigation system application software

Dental Imaging Software - 60889975319575

DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software

N/A - 07613327622782

SC+ AI Software
STRYKER CORPORATION
0894000004
In Commercial Distribution

  • 07613327622782 ()
0894-000-004

  • Blood loss estimation application software

FilmQA Pro - 00810106410845

Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
8.0
In Commercial Distribution

  • 00810106410845 ()
987957

  • Radiation therapy software

SmartPill - 07290110360481

SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system

Reflux - 07290110360429

Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system

LATITUDE® Clarity - 00802526613838

Device Services Software
BOSTON SCIENTIFIC CORPORATION
7260
In Commercial Distribution

  • 00802526613838 ()
7260

  • Patient health record information system application software

ManoScan - 07290101364009

ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution

  • 07290101364009 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365921

v3.0 software kit
Given Imaging, Inc.
FGS-0571
In Commercial Distribution

  • 07290101365921 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365778

v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution

  • 07290101365778 ()


  • Manometric gastrointestinal motility analysis system

Mano Scan - 07290101365754

ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution

  • 07290101365754 ()


  • Manometric gastrointestinal motility analysis system

Dental Imaging Software - 60192155319570

DENTAL IMAGING SOFTWARE
CARESTREAM DENTAL LLC
Dental Imaging Software
In Commercial Distribution

  • 60192155319570 ()
5319579

  • General-purpose dental x-ray system application software

Sales Demo Software - 60888937013483

Sales Demo Software
Coopersurgical, Inc.
23485-SRD
In Commercial Distribution

  • 60888937013483 ()


  • Urodynamic measurement system

SleepImage - B315SLEEPIMAGECOM0

Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier

CardioConfirm - 00817655020259

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-51    
In Commercial Distribution

  • 00817655020259 ()


  • Cardiology information system application software

CardioConfirm - 00817655020242

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-50    
In Commercial Distribution

  • 00817655020242 ()


  • Cardiology information system application software

TrueFit Software v5.4 - 07613389644579

TrueFit Software v5.4
Sonova AG
058-5178-054
In Commercial Distribution

  • 07613389644579 ()
058-5178-054

  • Audiometric/hearing device software

Clarity® - 07540180000221

Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution

  • 07540180000221 ()


  • Ultrasound patient positioning system

Clarity® - 07540180000207

Clarity® Software
Elekta Ltd
9310-00043
In Commercial Distribution

  • 07540180000207 ()


  • Ultrasound patient positioning system

FLUOROMAP - 07613252286578

FLUOROMAP 1.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6006-600-000
In Commercial Distribution

  • 07613252286578 ()
6006-600-000

  • Robotic surgical navigation system application software

True Lok System - 18054242511847

TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software

Navios Analysis Software - 15099590512453

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774953
In Commercial Distribution

  • 15099590512453 ()
774953

  • Laboratory instrument/analyser application software IVD

Navios Analysis Software - 15099590512125

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774951
In Commercial Distribution

  • 15099590512125 ()
774951

  • Laboratory instrument/analyser application software IVD

Navios Analysis Software - 15099590512118

Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774952
In Commercial Distribution

  • 15099590512118 ()
774952

  • Laboratory instrument/analyser application software IVD

Navios tetra Software - 15099590510756

Navios tetra Software
BECKMAN COULTER IRELAND INC.
775213
In Commercial Distribution

  • 15099590510756 ()
775213

  • Laboratory instrument/analyser application software IVD
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