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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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IH-Com V5.2 - 03610522123919

IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD

KneePlus - 03760297030315

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030315 ()
KNS002

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030469

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030469 ()
KNS170

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030322

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030322 ()
KNS160

  • Orthopaedic stereotactic surgery system

Portal - 03760297030148

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030148 ()
KNP001

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030124

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030124 ()
KNS002

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030117

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030117 ()
KNS002

  • Orthopaedic stereotactic surgery system

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

Vyaire - 04250892905914

SentrySuite Server Software Win 10
Jaeger Medical GmbH
V-577400-13
In Commercial Distribution

  • 04250892905914 ()
V-577400-13

  • Pulmonary function analysis system, adult

Natus - 00382830022309

Neuroworks/Sleepworks 8.1.0 (International) software
XLTEK
015418
In Commercial Distribution

  • 00382830022309 ()


  • Electroencephalograph

Natus - 00382830036160

EMG Software Upgrade to v22.4
NATUS NEUROLOGY INCORPORATED
688-628500
In Commercial Distribution

  • 00382830036160 ()


  • Electromyograph

Natus - 00382830036153

EMG Software Update to v22.3
NATUS NEUROLOGY INCORPORATED
688-628600
In Commercial Distribution

  • 00382830036153 ()


  • Electromyograph

Natus - 00382830035033

Natus Elite - Synergy Master Software
NATUS NEUROLOGY INCORPORATED
828-069300
In Commercial Distribution

  • 00382830035033 ()


  • Electromyograph

Natus - 00382830035026

Natus Elite - Viking Master Software
NATUS NEUROLOGY INCORPORATED
828-069400
In Commercial Distribution

  • 00382830035026 ()


  • Electromyograph

Xltek - 00382830048293

NeuroWorks/SleepWorks 9.2.1 Software (US)
XLTEK
024503
In Commercial Distribution

  • 00382830048293 ()


  • Electroencephalograph

Xltek - 00382830048279

NeuroWorks/SleepWorks 9.2.0 Software (INTL)
XLTEK
024501
In Commercial Distribution

  • 00382830048279 ()


  • Electroencephalograph

Xltek - 00382830048255

NeuroWorks/SleepWorks 9.1.1 Software (US)
XLTEK
024497
In Commercial Distribution

  • 00382830048255 ()


  • Electroencephalograph

Xltek - 00382830048231

NeuroWorks/SleepWorks 9.1.0 Software (INTL)
XLTEK
024495
In Commercial Distribution

  • 00382830048231 ()


  • Electroencephalograph

Natus - 00382830038027

Synergy EDX Application Software CD
NATUS NEUROLOGY INCORPORATED
482-645900
In Commercial Distribution

  • 00382830038027 ()


  • Electromyograph

Natus - 00382830037969

EMG v21.1.0 Application Software CD
NATUS NEUROLOGY INCORPORATED
482-651200
In Commercial Distribution

  • 00382830037969 ()


  • Electromyograph

PillCam - 10884521836181

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

  • 10884521836181 ()


  • Video capsule endoscopy system application software

PillCam - 10884521845916

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

  • 10884521845916 ()


  • Video capsule endoscopy system application software

EXACTECHGPS - 10885862518767

SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system

KARL STORZ SCB - 04048551060599

KARL STORZ SCB Software Upgrade
Karl Storz GmbH & Co. KG
20090001-28
In Commercial Distribution

  • 04048551060599 ()


  • Operating room audiovisual data/device management system application software

n.a. - 04048551329856

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-44
In Commercial Distribution

  • 04048551329856 ()


  • Operating room audiovisual data/device management system application software

n.a. - 04048551325117

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001S432
In Commercial Distribution

  • 04048551325117 ()


  • Operating room audiovisual data/device management system

n.a. - 04048551357286

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-45
In Commercial Distribution

  • 04048551357286 ()


  • Operating room audiovisual data/device management system application software

AESCULAP - 04046963372446

ORTHOPILOT SOFTWARE THA CUP ONLY
Aesculap AG
FS219
Not in Commercial Distribution

  • 04046963372446 ()
FS219

  • Robotic surgical navigation system application software

AESCULAP - 04046963895860

ORTHOPILOT SOFTWARE ACL SGL.+DBL.BUNDLE
Aesculap AG
FS227
Not in Commercial Distribution

  • 04046963895860 ()
FS227

  • Robotic surgical navigation system application software

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

AVEA - 10846446000979

KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software

Lumax™ - 60888937013445

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

  • 60888937013445 ()


  • Urodynamic measurement system

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

Vue RIS - 60889978671366

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

  • 60889978671366 ()
8671364

  • Radiology information system application software

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

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

Medoc Main Station Software - 07290103039011

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

  • 07290103039011 ()
SW 00012

  • Thermotester, diagnostic

Kaluza C - 15099590705169

Kaluza C Flow Cytometry Software
Beckman Coulter, Inc.
Flow Cytometry Software
In Commercial Distribution

  • 15099590705169 ()
C21166

  • Laboratory instrument/analyser application software IVD

moorFLPI-2 Clinical PC Software - 15060484490157

moorFLPI-2 Clinical PC Software V1
MOOR INSTRUMENTS LIMITED
1
Not in Commercial Distribution

  • 15060484490157 ()


  • Cutaneous microcirculation laser Doppler imaging device

moorFLPI2- Measurement PC Software - 15060484490126

moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490126 ()


  • Cutaneous microcirculation laser Doppler imaging device

moorFLPI-2 Review PC Software - 15060484490119

moorFLPI-2 Review PC Software V5
MOOR INSTRUMENTS LIMITED
5
In Commercial Distribution

  • 15060484490119 ()


  • Cutaneous microcirculation laser Doppler imaging device

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

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

Vivo 45 LS - 07321820070671

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

  • 07321820070671 ()
007067

  • Medical equipment clinical data interfacing software
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