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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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Delivery Analysis TM - M65810525910

Software, Delivery Analysis, Version 1.1
ACCURAY INCORPORATED
1052591
In Commercial Distribution

  • M65810525910 ()
NA

  • Linear accelerator system

IEM GmbH - 04041346100876

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.1.3
In Commercial Distribution

  • 04041346100876 ()


  • Medical equipment clinical data interfacing software

IEM GmbH - 04041346102207

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.3.x
In Commercial Distribution

  • 04041346102207 ()


  • Medical equipment clinical data interfacing software

IEM GmbH - 04041346102153

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.2.x
Not in Commercial Distribution

  • 04041346102153 ()


  • Medical equipment clinical data interfacing software

NA - 00840682107990

MR Applications Software MP24 R01
GENERAL ELECTRIC COMPANY
MP24
Not in Commercial Distribution

  • 00840682107990 ()


  • Full-body MRI system, superconducting magnet
  • PET system

Puritan Bennett - 10884521211551

IE Sync Trigger Software Update
Covidien LP
980IESYNC
In Commercial Distribution

  • 10884521211551 ()


  • Ventilator application software

INW Server - 00840682145756

Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

PillCam - 10884521836181

PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software

Vital Sync - 10884521815810

Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

INW Server - 00840682123563

SOFTWARE INW SERVER V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123563 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Vital Sync - 10884521851559

VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation

PillCam - 10884521845916

PillCam (TM) Desktop Software v9.7
Given Imaging, Inc.
FGS-0802
In Commercial Distribution

  • 10884521845916 ()


  • Video capsule endoscopy system application software

AVEA - 10846446064872

KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software

Somnostar - 10846446032260

SOFTWARE KIT LABMANAGER SQL PATCH
Carefusion Corporation
63783
Not in Commercial Distribution

  • 10846446032260 ()
63783

  • Home-use sleep apnoea recording system

CloudDR™ - B269SWR00021MD0

CloudDR™ Medical System Software
Cuattro Medical
SWR-00021-MD
In Commercial Distribution

  • B269SWR00021MD0 ()


  • Radiological PACS software

BioImp Body Composition Analysis Software SFB7 - B277299SFB7CD0

Bio Impedance analysis software ROW
IMPEDIMED LIMITED
5.5.0.1
In Commercial Distribution

  • B277299SFB7CD1 ()
  • B277299SFB7CD0 ()
299-SFB7CD

  • Bioelectrical body composition analyser

BioImp Body Composition Analysis Software SFB7 - B277293SFB7CD0

Bio Impedence analysis software US
IMPEDIMED LIMITED
5.5.0
In Commercial Distribution

  • B277293SFB7CD0 ()
  • B277293SFB7CD1 ()
293-SFB7CD

  • Bioelectrical body composition analyser

Body Composition Analysis Software - B277292DF50CD0

DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser

Segment CMR - 07350010100027

Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100027 ()


  • MRI system application software

Segment - 07350010100010

Software for medical image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100010 ()


  • Radiology DICOM image processing application software

Oxevision Sleep system - 50607514500023

Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only

N/A - 07613327542868

Ortho Guidance Versatile Hip Software
Stryker Leibinger GmbH & Co. KG
6007-700-000
In Commercial Distribution

  • 07613327542868 ()
6007-700-000

  • Robotic surgical navigation system application software

N/A - 07613327542332

Ortho Guidance Express Knee Software
Stryker Leibinger GmbH & Co. KG
6003-710-000
In Commercial Distribution

  • 07613327542332 ()
6003-710-000

  • Robotic surgical navigation system application software

N/A - 07613327541809

Ortho Guidance Precision Knee Software
Stryker Leibinger GmbH & Co. KG
6003-700-000
In Commercial Distribution

  • 07613327541809 ()
6003-700-000

  • Robotic surgical navigation system application software

NA - 07613327311822

ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management system

Vue RIS - 60889978671366

RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software

PROFESS - 07613327071955

PROFESS(TM) SOFTWARE SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81033
In Commercial Distribution

  • 07613327071955 ()
81-81033

  • Robotic surgical navigation system application software

PillCam - 07290110360795

PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741231124

Site~Rite 9 Ultrasound Software
Bard Access Systems, Inc.
SR9v1.1.0
In Commercial Distribution

  • 00801741231124 ()
SR9v1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741219221

SiteRite 9 Sherlock Software v3.3.1
Bard Access Systems, Inc.
Sherlockv3.3.1
In Commercial Distribution

  • 00801741219221 ()
Sherlockv3.3.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

CareLink™ Clinic - 00763000984762

PRODUCT SOFTWARE MMT-7350 PROWEB 4.1A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000984762 ()


  • Patient health record information system application software

MAXPOINT BR-I - 07290107983136

Transducer Array Layout Planning software
Novocure GmbH
1.1.0
In Commercial Distribution

  • 07290107983136 ()
SW000060

  • Alternating electric field antimitotic cancer treatment system generator

PillCam - 07290101369530

PillCam Software v9.0 WW WS
Given Imaging, Inc.
FGS-0626
In Commercial Distribution

  • 07290101369530 ()


  • Video capsule endoscopy system application software

ManoView - 07290101369059

AR v3.0 Software Upgrade kit
Given Imaging, Inc.
FGS-8031
In Commercial Distribution

  • 07290101369059 ()


  • Manometric gastrointestinal motility analysis system

PillCam - 07290101366768

PillCam Software Upgrade v9 , USA
Given Imaging, Inc.
FGS-0613
In Commercial Distribution

  • 07290101366768 ()


  • Video capsule endoscopy system application software

Medoc Main Station Software - 07290103039011

Medoc Main Station Base Software
MEDOC LTD.
MMS
In Commercial Distribution

  • 07290103039011 ()
SW 00012

  • Thermotester, diagnostic

NA - 07613154481118

FLUOROSCOPY SOFTWARE 2.3 CD-SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80037
In Commercial Distribution

  • 07613154481118 ()
81-80037

  • Robotic surgical navigation system application software

Lumax™ - 60888937013445

Lumax™ Software Update pack
Coopersurgical, Inc.
53361
In Commercial Distribution

  • 60888937013445 ()


  • Urodynamic measurement system

IH-Com V5.0 - 07611969234417

IH-Com V5.0, Software Version 5.0.10
Bio-Rad Medical Diagnostics GmbH
5.0.10
In Commercial Distribution

  • 07611969234417 ()
009101

  • Laboratory instrument/analyser application software IVD

Welch Allyn, Inc. - 00817655021294

DVD SOFTWARE XScribe CP v4.0.3
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00817655021294 ()
420181

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00817655020952

Hscribe Web Upload software kit
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00817655020952 ()
88188-001-50

  • Centralized patient monitor

Arthrex® - 00888867226975

Synergy.Net HL7 Software Single License
ARTHREX, INC.
AR-3200-1047
In Commercial Distribution

  • 00888867226975 ()
AR-3200-1047

  • Medical image management system

Unitron - 07613389303285

TrueFit Fitting Software v4.x
Unitron Hearing Division
058-5235
In Commercial Distribution

  • 07613389303285 ()
058-5235

  • Audiometric/hearing device software

Unitron - 07613389303292

AuraFit Fitting Software v4.x
Unitron Hearing Division
058-5236
In Commercial Distribution

  • 07613389303292 ()
058-5236

  • Audiometric/hearing device software

Vivo 50, VIvo 65 - 07321820051007

Vivo 50/65 PC Software
Breas Medical AB
005100
In Commercial Distribution

  • 07321820051007 ()
005100

  • Medical equipment clinical data interfacing software

Vivo 45 LS - 07321820070671

PC Software Vivo 45 LS
Breas Medical AB
007067
In Commercial Distribution

  • 07321820070671 ()
007067

  • Medical equipment clinical data interfacing software

CareLink™ - 00763000424138

PRODUCT SOFTWARE MMT-7350 PROWEB 3.13A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000424138 ()


  • Patient health record information system application software

Synergy®Cranial - 00763000253158

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00763000253158 ()


  • Multi-purpose stereotactic surgery system

uWS - 06971576834037

PET/CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MI
In Commercial Distribution

  • 06971576834037 ()


  • Radiology DICOM image processing application software
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