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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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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

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

X-Guide FastMap - 00817421022852

FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory

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

ELI Edit - 00812345025217

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system

CardioConfirm - 00812345024715

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-51    
In Commercial Distribution

  • 00812345024715 ()


  • Cardiology information system application software

CardioConfirm - 00812345024708

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-50    
In Commercial Distribution

  • 00812345024708 ()


  • Cardiology information system application software

ELI Edit - 00812345023459

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution

  • 00812345023459 ()


  • Patient health record information system

C7-XR™ - 00812059021536

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
C.0.4 Software Upgrade
In Commercial Distribution

  • 00812059021536 ()
15211-01

  • Coronary optical coherence tomography system

ILUMIEN™ - 00812059021482

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution

  • 00812059021482 ()
100074942

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021390

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system

ILUMIEN™ - 00812059021383

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution

  • 00812059021383 ()
C408656

  • Coronary optical coherence tomography system

ILUMIEN™ - 00812059020560

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1.1 Software
In Commercial Distribution

  • 00812059020560 ()
100111860

  • Coronary optical coherence tomography system

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

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

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

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

CuattroDR - B269SWR00069MD0

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

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

StimRouter - 00815962020306

Clinician Programmer Software
BIONESS INC.
ST2-SW01
In Commercial Distribution

  • 00815962020306 ()


  • Transcutaneous electrical stimulation probe

H200 Wireless - 00815962020290

Clinician Programmer Software
BIONESS INC.
H2W-SW01
In Commercial Distribution

  • 00815962020290 ()


  • Hand orthosis

Arthrex® - 00888867100626

Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution

  • 00888867100626 ()
AR-3200-1030

  • Operating room audiovisual data/device management system

MyShoulder Planner - 07630542730153

MyShoulder Planner Software
Medacta International SA
5.3SSWPL
In Commercial Distribution

  • 07630542730153 ()


  • Orthopaedic/craniofacial implantation planning software

MySpine Webplanner & MyBalance - 07630345725905

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

  • 07630345725905 ()


  • Orthopaedic/craniofacial implantation planning software

Sales Demo Software - 60888937013483

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

  • 60888937013483 ()


  • Urodynamic measurement system

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

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

FilmQA Pro - 00810106410845

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

  • 00810106410845 ()
987957

  • Radiation therapy software

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

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

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
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