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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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OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter
Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system
Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution

  • B147CA0 ()


  • Electrocardiography telemetric monitoring system
CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software
MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software
SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation
SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation
SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software
SWR KIT SSPRO SOFTWARE VER 10.2
Carefusion Corporation
22312-001
Not in Commercial Distribution

  • 10846446031485 ()
22312-001

  • Home-use sleep apnoea recording system
SOFTWARE KIT VMAX ENCORE VER 21-1
Carefusion Corporation
63792
Not in Commercial Distribution

  • 10846446027693 ()
63792

  • Pulmonary function analysis system, adult
  • Pulmonary function analysis system, paediatric
SWR KIT SSPRO SOFTWARE VER 11
Carefusion Corporation
28008-001
Not in Commercial Distribution

  • 10846446032550 ()
28008-001

  • Home-use sleep apnoea recording system
SWR KIT SSPRO SOFTWARE VER 9
Carefusion Corporation
63734
Not in Commercial Distribution

  • 10846446020274 ()
63734

  • Home-use sleep apnoea recording system
Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.04
In Commercial Distribution

  • 03573026626471 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.03
In Commercial Distribution

  • 03573026613914 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system
OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary
OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


  • CT contrast medium injection system, line-powered, stationary
Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-006-70
In Commercial Distribution

  • 00817655021447 ()


  • Electrocardiography telemetric monitoring system
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