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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OnPoint Surgical Cart (with pre-installed software) - 1 headset
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682010 ()
NK0210101

  • Orthopaedic stereotactic surgery system
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.4.1
In Commercial Distribution

  • 00850049633253 ()
8.4.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.4.0
In Commercial Distribution

  • 00850049633246 ()
8.4.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.3.0
In Commercial Distribution

  • 00850049633239 ()
8.3.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.2.0
In Commercial Distribution

  • 00850049633161 ()
8.2.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.1
In Commercial Distribution

  • 00850049633130 ()
8.1.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.1.0
In Commercial Distribution

  • 00850049633123 ()
8.1.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.0.1
In Commercial Distribution

  • 00850049633109 ()
8.0.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
8.0.0
In Commercial Distribution

  • 00850049633055 ()
8.0.0

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.5
In Commercial Distribution

  • 00850049633048 ()
7.1.5

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.2
In Commercial Distribution

  • 00850049633031 ()
7.1.2

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.1
In Commercial Distribution

  • 00850049633024 ()
7.1.1

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
6.0 SP9 Patch 2
In Commercial Distribution

  • 00850049633017 ()
6.0 SP9 Patch 2

  • Medical equipment clinical data interfacing software
RALS test results capturing and data transferring software
Abbott Rapid Diagnostics Informatics, Inc.
7.1.4
In Commercial Distribution

  • 00850049633000 ()
7.1.4

  • Medical equipment clinical data interfacing software
Computer workstation used in conjunction with TeleRehab software.
SCOTTCARE CORPORATION, THE
TeleRehab Computer
In Commercial Distribution

  • 00856298006275 ()
101819

  • Desktop computer
Reader Control v2.2 for Exact Sciences System Software
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005833 ()


  • Laboratory instrument/analyser application software IVD
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Quarterly
LIDCO LIMITED
Li11076Q
In Commercial Distribution

  • 05060110523054 ()
Li11076Q

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Monthly
LIDCO LIMITED
Li11076M
In Commercial Distribution

  • 05060110523047 ()
Li11076M

  • General-purpose multi-parameter bedside monitor
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Annual
LIDCO LIMITED
Li11076A
In Commercial Distribution

  • 05060110523023 ()
Li11076A

  • General-purpose multi-parameter bedside monitor
Leica Biosystems CytoVision FISH review software (inc. dongle)
Leica Biosystems Richmond, Inc.
23SWR000FXX001
Not in Commercial Distribution

  • 00849832004318 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision FISH Software License Activition Code
Leica Biosystems Richmond, Inc.
23SWR000FLX001
Not in Commercial Distribution

  • 00849832004301 ()

  • Device Size Text, specify:


  • Microscope objective
Leica Biosystems CytoVision CGH Software License Activation Code
Leica Biosystems Richmond, Inc.
23SWR000CGX001
Not in Commercial Distribution

  • 00849832004288 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
PC Software for Digital BP,w/USB Cable
AMERICAN DIAGNOSTIC CORP
6023NPC
In Commercial Distribution

  • 00634782075941 ()
6023NPC

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
PC Software for BP Unit,w/USB Cable
AMERICAN DIAGNOSTIC CORP
6017PC
Not in Commercial Distribution

  • 00634782058470 ()
6017PC

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Software Upgrade Kit, 30 day license, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026200 ()
H702500-T

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

  • 05415067042477 ()
ENSITE-D-AM-2.0

  • Cardiac mapping system application software
X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software
X EP System LiveView Dynamic Display Software License
ST. JUDE MEDICAL, INC.
ENSITE-LV-01
In Commercial Distribution

  • 05415067037718 ()
ENSITE-LV-01

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

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-03
In Commercial Distribution

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-02
In Commercial Distribution

  • 05415067051110 ()
ENSITE-FWV-02

  • Cardiac mapping system application software
X EP System PFA Catheter Visualization Software License
ST. JUDE MEDICAL, INC.
ENSITE-FWV-01
In Commercial Distribution

  • 05415067050298 ()
ENSITE-FWV-01

  • Cardiac mapping system application software
X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

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

  • 05415067048363 ()
ENSITE-D-AMD-01

  • Cardiac mapping system application software
Siesta 802 Basic EEG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic EEG System
In Commercial Distribution

  • 09342451002112 ()
9007-0061-01

  • Electroencephalographic ambulatory recorder
Siesta 802 Basic PSG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic PSG System
In Commercial Distribution

  • 09342451001788 ()
9007-0060-00

  • Polysomnograph
VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.3
In Commercial Distribution

  • 09421904268098 ()


  • Radiology DICOM image processing application software
Software Kit for SVM-7200 Series Vital Signs Monitor
NIHON KOHDEN CORPORATION
QS-126P
In Commercial Distribution

  • 04931921006054 ()
QS-126P

  • General-purpose multi-parameter bedside monitor
Applied Speech Science for Voice & Resonance Disorders, Software
PENTAX OF AMERICA, INC.
5156
Not in Commercial Distribution

  • 04961333229871 ()


  • Electroglottograph
Vocal Parts and Vocal Pathology I & II Software
PENTAX OF AMERICA, INC.
9225
In Commercial Distribution

  • 04961333230358 ()


  • Electroglottograph
Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.
ELECTRICAL GEODESICS, INC.
GeoSource 2.0
Not in Commercial Distribution

  • 00863003000343 ()


  • Electroencephalograph
Welch Allyn Diagnostic Cardiology Suite Spirometry; Software Only
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094323993 ()
DCSS-SXA

  • Diagnostic spirometer, professional
Welch Allyn Connex Central Station Software; v 1.5
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094195408 ()
1000994

  • Centralized patient monitor
Platform software application for data collection and analysis
PREVENTICE TECHNOLOGIES, INC.
SW1001
In Commercial Distribution

  • 00852132007286 ()


  • Cardiopulmonary physiological parameter analysis software
BD FACSuite™ Clinical Flow Cytometry Software v1.3
Becton, Dickinson And Company
663003
In Commercial Distribution

  • 00382906630032 ()
663003

  • Laboratory instrument/analyser application software IVD
BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD
EMG v22 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630300
In Commercial Distribution

  • 00382830045070 ()


  • Electromyograph
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.21
In Commercial Distribution

  • 00606959056329 ()
1126366

  • Medical equipment clinical data interfacing software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.22
In Commercial Distribution

  • 00606959056909 ()
1126366

  • Medical equipment clinical data interfacing software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.20
In Commercial Distribution

  • 00606959056084 ()
1126366

  • Medical equipment clinical data interfacing software
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