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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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1.0 Software Update vF.0.1
ST. JUDE MEDICAL, INC.
1015191
In Commercial Distribution

  • 05415067045331 ()
1015191

  • Coronary optical coherence tomography system
SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN CORPORATION
QP-260BK
In Commercial Distribution

  • 04931921113080 ()
QP-260BK

  • Evoked-potential graphic recording system
Software Kit (for CU-171R, CU-172R)
NIHON KOHDEN CORPORATION
QS-127P
In Commercial Distribution

  • 04931921006689 ()
QS-127P

  • General-purpose multi-parameter bedside monitor
Software Kit (for CU-151R, CU-152R)
NIHON KOHDEN CORPORATION
QS-116P
In Commercial Distribution

  • 04931921002179 ()
QS-116P

  • General-purpose multi-parameter bedside monitor
Protocol Plus Software version 10.3
G&J Electronics Inc
PPS-10.3
In Commercial Distribution

  • 00627843670957 ()


  • Gastrointestinal barostat
Protocol Plus Version 9.8 software
G&J Electronics Inc
PPS-9.8
In Commercial Distribution

  • 00627843670940 ()


  • Gastrointestinal barostat
Nueroscience for Human Communication, Software
PENTAX OF AMERICA, INC.
5155
In Commercial Distribution

  • 04961333229864 ()


  • Electroglottograph
Phonetic & Perception Simulation Program, Software
PENTAX OF AMERICA, INC.
5151
Not in Commercial Distribution

  • 04961333229826 ()


  • Electroglottograph
Multi-Dimensional Voice Program (MDVP) Software
PENTAX OF AMERICA, INC.
5105
In Commercial Distribution

  • 04961333229741 ()


  • Electroglottograph
Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface
dental implant surgical guide software
GuidePro3D
1.0
In Commercial Distribution

  • 00864551000304 ()


  • Dental treatment application software
Kinesia 360 Support Application Software
Great Lakes Neurotechnologies Inc.
360-0048, Support Application Software
In Commercial Distribution

  • 00859584006171 ()


  • Tremor transducer
STarFix™ Designer Software, Version
FHC, INC.
C0265-00860
In Commercial Distribution

  • 00873263008607 ()
C0265

  • Stereotactic neuronavigation/planning system
MR-RT RTgo software USB stick
Philips Oy
459801266633
In Commercial Distribution

  • 00884838092112 ()


  • MRI system application software
MR-RT RTgo software USB stick
Philips Oy
989603083082
In Commercial Distribution

  • 00884838084667 ()


  • MRI system application software
SOFTWARE 9730877 ORTHO LICENSE (PLUS)
MEDTRONIC NAVIGATION, INC.
9730877
Not in Commercial Distribution

  • 00721902849787 ()


  • Multi-purpose stereotactic surgery system
DVD SOFTWARE RScribe Lite v1.0.2
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094325300 ()
419614

  • Electrocardiograph, professional, multichannel
SOFTWARE SURVYOR CENTRAL REPEATER DVD
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094319903 ()
419832

  • Centralized patient monitor
WADCS ECG SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315493 ()
729324

  • Electrocardiograph, professional, multichannel
WADCS SPIRO SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315486 ()
729325

  • Electrocardiograph, professional, multichannel
WADCS MANAGER SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315479 ()
729326

  • Electrocardiograph, professional, multichannel
Q-TEL V5.0.1 Q-PROGRESS SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307375 ()
419733

  • Centralized patient monitor
Q-TEL V5.0.1 Workstation Software CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307368 ()
413379

  • Centralized patient monitor
QTEL v5.0.1 TOWER SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307351 ()
419751

  • Centralized patient monitor
ELI LINK V4.5.1 SOFTWARE DVD
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094300710 ()
413225

  • Electrocardiograph, professional, multichannel
SOFTWARE MONITIOR WAVEFORM VIEWER V2.1.0
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094296341 ()
11093-003-50

  • Cardiology information system application software
SOFTWARE ARRHYTHMIA ST LIBRARY v6.0.3
WELCH ALLYN, INC.
901008
In Commercial Distribution

  • 00732094272345 ()
11091-002-50

  • Centralized patient monitor
CONNEX CS SOFTWARE DELIVERY PHANTOM
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250879 ()
411066

  • Centralized patient monitor
TAGCONNECT SOFTWARE AND SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094212464 ()
TAGECG-SW

  • Electrocardiographic ambulatory recorder
TS1200CL TELESTETH SOFTWARE HOSTED LICENSE
3M COMPANY
TS1200CL
In Commercial Distribution

  • 00707387766597 ()
TS1200CL

  • Stethoscope application software
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