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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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IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030315 ()
KNS002

  • Orthopaedic stereotactic surgery 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

  • 03760297030148 ()
KNP001

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

  • 03760297030124 ()
KNS002

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

  • 03760297030117 ()
KNS002

  • Orthopaedic stereotactic surgery system
Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit
SentrySuite Server Software Win 10
Jaeger Medical GmbH
V-577400-13
In Commercial Distribution

  • 04250892905914 ()
V-577400-13

  • Pulmonary function analysis system, adult
Neuroworks/Sleepworks 8.1.0 (International) software
XLTEK
015418
In Commercial Distribution

  • 00382830022309 ()


  • Electroencephalograph
EMG Software Upgrade to v22.4
NATUS NEUROLOGY INCORPORATED
688-628500
In Commercial Distribution

  • 00382830036160 ()


  • Electromyograph
EMG Software Update to v22.3
NATUS NEUROLOGY INCORPORATED
688-628600
In Commercial Distribution

  • 00382830036153 ()


  • Electromyograph
Natus Elite - Synergy Master Software
NATUS NEUROLOGY INCORPORATED
828-069300
In Commercial Distribution

  • 00382830035033 ()


  • Electromyograph
Natus Elite - Viking Master Software
NATUS NEUROLOGY INCORPORATED
828-069400
In Commercial Distribution

  • 00382830035026 ()


  • Electromyograph
NeuroWorks/SleepWorks 9.2.1 Software (US)
XLTEK
024503
In Commercial Distribution

  • 00382830048293 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.2.0 Software (INTL)
XLTEK
024501
In Commercial Distribution

  • 00382830048279 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.1.1 Software (US)
XLTEK
024497
In Commercial Distribution

  • 00382830048255 ()


  • Electroencephalograph
NeuroWorks/SleepWorks 9.1.0 Software (INTL)
XLTEK
024495
In Commercial Distribution

  • 00382830048231 ()


  • Electroencephalograph
Synergy EDX Application Software CD
NATUS NEUROLOGY INCORPORATED
482-645900
In Commercial Distribution

  • 00382830038027 ()


  • Electromyograph
EMG v21.1.0 Application Software CD
NATUS NEUROLOGY INCORPORATED
482-651200
In Commercial Distribution

  • 00382830037969 ()


  • Electromyograph
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