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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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Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system
FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory
Clinician Programmer Software
BIONESS INC.
ST2-SW01
In Commercial Distribution

  • 00815962020306 ()


  • Transcutaneous electrical stimulation probe
Clinician Programmer Software
BIONESS INC.
H2W-SW01
In Commercial Distribution

  • 00815962020290 ()


  • Hand orthosis
WebPlanner Spine Software
Medacta International SA
98.46.WEBPSPINE
In Commercial Distribution

  • 07630345725905 ()


  • Orthopaedic/craniofacial implantation planning software
Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution

  • 00888867100626 ()
AR-3200-1030

  • Operating room audiovisual data/device management system
CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital
Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier
StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system
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