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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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Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit
PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software
Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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
VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation
PillCam (TM) Desktop Software v9.7
Given Imaging, Inc.
FGS-0802
In Commercial Distribution

  • 10884521845916 ()


  • Video capsule endoscopy 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
CloudDR™ Medical System Software
Cuattro Medical
SWR-00021-MD
In Commercial Distribution

  • B269SWR00021MD0 ()


  • Radiological PACS software
Bio Impedance analysis software ROW
IMPEDIMED LIMITED
5.5.0.1
In Commercial Distribution

  • B277299SFB7CD1 ()
  • B277299SFB7CD0 ()
299-SFB7CD

  • Bioelectrical body composition analyser
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