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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

AESCULAP - 04046955206810

SOFTWARE MODULE DICOM
Aesculap AG
PV024
In Commercial Distribution

  • 04046955206810 ()
PV024

  • Neurosurgical microscope

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

MAXFRAME - 10886982260949

MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution

  • 07612334140258 ()
  • H679033120000 ()
  • 10886982260949 ()
03312000

  • External orthopaedic fixation frame calculation 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

Sentinel - 10841522125751

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

  • 10841522125751 ()
98201

  • Cardiology information system application software

ILLUMISITE - 10884521779990

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

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking 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

superDimension - 10884521747425

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

  • 10884521747425 ()


  • Electromagnetic surgical navigation device tracking system

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

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

EVASOFT - D83399924908000

EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software

DWOS Chairside - D840DWOSCS1

Dental CADCAM Software
Dental Wings Inc
2
In Commercial Distribution

  • D840DWOSCS1 ()


  • Dental milling system, CAD/CAM, chairside

DWOS - D840DWOSCAD1

Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory

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 - 04038653423316

ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software

N/A - 07613327622782

SC+ AI Software
STRYKER CORPORATION
0894000004
In Commercial Distribution

  • 07613327622782 ()
0894-000-004

  • Blood loss estimation application software

SurgiCount - 07613327622751

+ Sponge Counting Software
STRYKER CORPORATION
0894000003
In Commercial Distribution

  • 07613327622751 ()
0894-000-003

  • 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

N/A - 07613327568998

QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter

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

CHRONO-LOG - 00811476011045

vW CoFactor Software
CHRONO-LOG CORP
vW CoFactor Software
In Commercial Distribution

  • 00811476011045 ()


  • Platelet aggregation analyser IVD

CHRONO-LOG - 00811476011021

AGGRO/LINK8 Software
CHRONO-LOG CORP
AGGRO/LINK8 Software
In Commercial Distribution

  • 00811476011021 ()


  • Platelet aggregation analyser IVD

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

X-Guide FastMap - 00817421022852

FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory

ELI Edit - 00817655022796

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

  • 00817655022796 ()


  • Patient health record information system

CardioConfirm - 00817655022772

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-003-51
In Commercial Distribution

  • 00817655022772 ()


  • Cardiology information system application software

CardioConfirm - 00817655022765

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-003-50
In Commercial Distribution

  • 00817655022765 ()


  • Cardiology information 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

Sales Demo Software - 60888937013483

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

  • 60888937013483 ()


  • Urodynamic measurement 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

FilmQA Pro - 00810106410845

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

  • 00810106410845 ()
987957

  • Radiation therapy software

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

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

MySpine Webplanner & MyBalance - 07630345725905

WebPlanner Spine Software
Medacta International SA
98.46.WEBPSPINE
In Commercial Distribution

  • 07630345725905 ()


  • Orthopaedic/craniofacial implantation planning software
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