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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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Leica CytoVision Karyotyping review software (incl. dongle)
Leica Biosystems Richmond, Inc.
23SWR000KXX001
Not in Commercial Distribution

  • 00849832003656 ()

  • Device Size Text, specify:


  • Laboratory analyser operation system software IVD
Leica Biosystems CytoVision Karyotyping Software License Activation
Leica Biosystems Richmond, Inc.
23SWR000KLX001
Not in Commercial Distribution

  • 00849832003649 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping & FISH Review software
Leica Biosystems Richmond, Inc.
23SWR000KFX001
Not in Commercial Distribution

  • 00849832003632 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext)
LIDCO LIMITED
Li11076
In Commercial Distribution

  • 05060110522330 ()
Li11076

  • General-purpose multi-parameter bedside monitor
SOFTWARE KIT 9733652 FUSION SW WITH PG
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00613994378798 ()


  • ENT stereotactic surgery system
SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
SOFTWARE KIT 9733652XOM FUSION SW W/PG
MEDTRONIC NAVIGATION, INC.
9733652XOM
In Commercial Distribution

  • 00613994469199 ()


  • ENT stereotactic surgery system
SFTWR KIT 9733933XOM DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933XOM
In Commercial Distribution

  • 00613994481115 ()


  • Multi-purpose stereotactic surgery system
SFTWR KIT 9733933 DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933
In Commercial Distribution

  • 00613994467072 ()


  • Multi-purpose stereotactic surgery system
Digital stethoscope and hosted software application solution.
Globalmed Holdings, LLC
GSW30100103
In Commercial Distribution

  • 00850033167108 ()
GSW30100103

  • Stethoscope application software
Software Installation, 30 day trial, v.3.0
ST. JUDE MEDICAL, INC.
H702501-T
In Commercial Distribution

  • 05415067026187 ()
H702501-T

  • Cardiac mapping system application software
Software Installation, 30 day trial, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496-T
In Commercial Distribution

  • 05415067026118 ()
H702496-T

  • Cardiac mapping system application software
X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-02
In Commercial Distribution

  • 05415067049988 ()
ENSITE-OTAC-02

  • Cardiac mapping system application software
X EP System LiveSync Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LS-01
In Commercial Distribution

  • 05415067048387 ()
ENSITE-D-LS-01

  • Cardiac mapping system application software
X EP System AutoMark Distance Software License
ST. JUDE MEDICAL, INC.
ENSITE-AMD-01
In Commercial Distribution

  • 05415067048332 ()
ENSITE-AMD-01

  • Cardiac mapping system application software
X EP System EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system
X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-01
In Commercial Distribution

  • 05415067046642 ()
ENSITE-OTAC-01

  • Cardiac mapping system application software
X EP System Advanced Mapping Software License
ST. JUDE MEDICAL, INC.
ENSITE-AM-2.0
In Commercial Distribution

  • 05415067042507 ()
ENSITE-AM-2.0

  • Cardiac mapping system application software
X EP System Live Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-LE-01
In Commercial Distribution

  • 05415067037732 ()
ENSITE-LE-01

  • Cardiac mapping system application software
X EP System Omnipolar Technology Software License
ST. JUDE MEDICAL, INC.
ENSITE-OT-01
In Commercial Distribution

  • 05415067037701 ()
ENSITE-OT-01

  • Cardiac mapping system application software
Encore Pro 2, Patient Management Software (DVD)
Respironics, Inc.
Encore Pro Patient Management Software - 2
In Commercial Distribution

  • 00606959053793 ()
1054785

  • Medical equipment clinical data interfacing software
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
EncoreAnywhere Data Management Software (U.S. - North America)
Respironics, Inc.
2.35
In Commercial Distribution

  • 00606959047228 ()
1119756

  • Medical equipment clinical data interfacing software
EncoreAnywhere Data Management Software (North American Instance)
Respironics, Inc.
2.32
In Commercial Distribution

  • 00606959042902 ()
1119756

  • Medical equipment clinical data interfacing software
To support the 7.x software version
Philips Ultrasound LLC
795125
In Commercial Distribution

  • 00884838109971 ()


  • General-purpose ultrasound imaging system
Guideline™ 4000 5.0 Software, Version 2.2.0
FHC, INC.
C0217-00864
In Commercial Distribution

  • 00873263008645 ()
C0217

  • Neurophysiologic monitoring system
  • Electroencephalograph
ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
Fujirebio Diagnostics, Inc.
404-10US
In Commercial Distribution

  • 00869164000024 ()


  • Laboratory instrument/analyser application software IVD
microTargeting WayPoint Navigato, Laptop and Software, 1x
FHC, INC.
66-WP-NV(4.2)-00433
Not in Commercial Distribution

  • 00873263004333 ()
66-WP-NV(4.2)

  • Neurological stereotactic surgery system
Dental imaging capture, enhance and display software.
APTERYX INC
3
In Commercial Distribution

  • 00685031000023 ()


  • General-purpose dental x-ray system application software
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