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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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CDR DICOM - D764B10301910

CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software

n.a. - 04048551228517

KARL STORZ SCB Software Upgrade "VOICE1"
Karl Storz GmbH & Co. KG
20090001-40
In Commercial Distribution

  • 04048551228517 ()


  • Operating room audiovisual data/device management system application software

Senolris - 00840682104395

SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation

SenoIris - 00840682147767

SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation

SenoIris - 00840682140614

SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation

NA - 00840682124591

MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software

GE Client Workstation - 00840682123594

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

Somnostar - 10846446020274

SWR KIT SSPRO SOFTWARE VER 9
Carefusion Corporation
63734
Not in Commercial Distribution

  • 10846446020274 ()
63734

  • Home-use sleep apnoea recording system

Vmax - 10846446027693

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

AVEA - 10846446064865

KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software
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