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

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software
Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit
PillCam (TM) Desktop Software v9.7
Given Imaging, Inc.
FGS-0802
In Commercial Distribution

  • 10884521845916 ()


  • Video capsule endoscopy system application software
PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software
VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation
Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
ORTHOPILOT SOFTWARE THA CUP ONLY
Aesculap AG
FS219
Not in Commercial Distribution

  • 04046963372446 ()
FS219

  • Robotic surgical navigation system application software
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
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
KIT,AVEA UPGRADE GDE & SOFTWARE
Carefusion Corporation
12284-PMN
Not in Commercial Distribution

  • 10846446064872 ()
12284-PMN

  • Ventilator application software
SOFTWARE KIT LABMANAGER SQL PATCH
Carefusion Corporation
63783
Not in Commercial Distribution

  • 10846446032260 ()
63783

  • Home-use sleep apnoea recording system
KIT,ET-CO2 MODULE W/SOFTWARE
Carefusion Corporation
16920
Not in Commercial Distribution

  • 10846446012705 ()
16920

  • Carbon dioxide sensor/cable
KIT,AVEA UPGRADE UIM & SOFTWARE
Carefusion Corporation
12285
Not in Commercial Distribution

  • 10846446000979 ()


  • Ventilator application software
ORTHOPILOT SOFTWARE ACL SGL.+DBL.BUNDLE
Aesculap AG
FS227
Not in Commercial Distribution

  • 04046963895860 ()
FS227

  • Robotic surgical navigation system application software
SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system
AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Medipixel
V1.0.0
In Commercial Distribution

  • 08800127400040 ()


  • Radiology DICOM image processing application software
IE Sync Trigger Software Update
Covidien LP
980IESYNC
In Commercial Distribution

  • 10884521211551 ()


  • Ventilator application software
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
MR Applications Software MP24 R01
GENERAL ELECTRIC COMPANY
MP24
Not in Commercial Distribution

  • 00840682107990 ()


  • Full-body MRI system, superconducting magnet
  • PET system
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.3.x
In Commercial Distribution

  • 04041346102207 ()


  • Medical equipment clinical data interfacing software
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.2.x
Not in Commercial Distribution

  • 04041346102153 ()


  • Medical equipment clinical data interfacing software
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.1.3
In Commercial Distribution

  • 04041346100876 ()


  • Medical equipment clinical data interfacing software
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
Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030469 ()
KNS170

  • Orthopaedic stereotactic surgery system
Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030322 ()
KNS160

  • Orthopaedic stereotactic surgery system
Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030315 ()
KNS002

  • Orthopaedic stereotactic surgery system
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
Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030148 ()
KNP001

  • Orthopaedic stereotactic surgery system
Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030124 ()
KNS002

  • Orthopaedic stereotactic surgery system
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