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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 - M65810573750

Software, Delivery Analysis, Version 1.2
ACCURAY INCORPORATED
1057375
In Commercial Distribution

  • M65810573750 ()
NA

  • Linear accelerator system

Delivery Analysis TM - M65810525910

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

  • M65810525910 ()
NA

  • Linear accelerator system

Monarch™ Cart Software v4.1.1 - 10810068811503

Monarch™ Cart Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811503 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.1 - 10810068811497

Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.2.5 - 10810068810773

Monarch™ Software Cart v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810773 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.2.5 - 10810068810766

Monarch™ Software Tower v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810766 ()


  • Robotic surgical system application software

Monarch™ Cart Software v4.1.0 - 10810068810599

Monarch™ Cart Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810599 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.0 - 10810068810582

Monarch™ Tower Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810582 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.2.4 - 10810068810483

Monarch™ Software Cart v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810483 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.2.4 - 10810068810476

Monarch™ Software Tower v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810476 ()


  • Robotic surgical system application software

VITEK®2 - 03573026609399

CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

NUCLISENS® easyMAG® SOFTWARE V2. 1 - 03573026448301

EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

Vivistim - 10810041430004

Stroke Application and Programming Software
Microtransponder
4001
In Commercial Distribution

  • 10810041430004 ()


  • Vagus nerve electrical stimulation system programmer

MPXA - 08800127400040

AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Medipixel
V1.0.0
In Commercial Distribution

  • 08800127400040 ()


  • Radiology DICOM image processing application software

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

NA - 00840682107990

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

  • 00840682107990 ()


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

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

Vela - 10846446012705

KIT,ET-CO2 MODULE W/SOFTWARE
Carefusion Corporation
16920
Not in Commercial Distribution

  • 10846446012705 ()
16920

  • Carbon dioxide sensor/cable

AVEA - 10846446000979

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

  • 10846446000979 ()


  • Ventilator application software

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

Puritan Bennett - 10884521211551

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

  • 10884521211551 ()


  • Ventilator application software

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

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

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

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

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

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

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

AESCULAP - 04046963372446

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

  • 04046963372446 ()
FS219

  • Robotic surgical navigation system application software

EXACTECHGPS - 10885862518767

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

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system

AESCULAP - 04046963895860

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

  • 04046963895860 ()
FS227

  • Robotic surgical navigation system 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

KneePlus - 03760297030117

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
Not in Commercial Distribution

  • 03760297030117 ()
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

KneePlus - 03760297030315

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

  • 03760297030315 ()
KNS002

  • 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

Sonata® System Software - 10817929020357

Ultrasound-guided radio-frequency ablation system software
Gynesonics, Inc.
SW-001
Not in Commercial Distribution

  • 10817929020357 ()
SW-001

  • Ultrasound-guided radio-frequency ablation system software

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

Oxevision Sleep system - 50607514500023

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

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only

PULSOX-300i - 00817770020547

Oximeter Sleep Study without Software
MAXTEC, LLC
R204P18-001
Not in Commercial Distribution

  • 00817770020547 ()


  • Pulse oximeter

EPIgray - B501EPIGRAY020010

Radiotherapy quality assurance software tool.
DOSISOFT
2.0.10
In Commercial Distribution

  • B501EPIGRAY020010 ()
EP1001

  • Radiation therapy software

EPIgray - B501EPIGRAY020007

Radiotherapy software quality assurance tool
DOSISOFT
2.0.7
In Commercial Distribution

  • B501EPIGRAY020007 ()
2.0.7

  • Radiation therapy software
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