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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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CHRONO-LOG - 00811476011670

vW CoFactor Opti8 Software
CHRONO-LOG CORP
vW CoFactor Opti8 Software
In Commercial Distribution

  • 00811476011670 ()


  • Platelet aggregation analyser IVD

CHRONO-LOG - 00811476011663

AGGRO/LINK Opti8 Software
CHRONO-LOG CORP
AGGRO/LINK Opti8 Software
In Commercial Distribution

  • 00811476011663 ()


  • Platelet aggregation analyser IVD

CHRONO-LOG - 00811476011007

AGGRO/LINK WBA Software
CHRONO-LOG CORP
AGGRO/LINK WBA Software
In Commercial Distribution

  • 00811476011007 ()


  • Platelet aggregation analyser IVD

StealthStation® Cranial - 00763000095741

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000095741 ()


  • Neurological stereotactic surgery system

Welch Allyn, Inc. - 00732094320800

XSCRIBE V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320800 ()
419540

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094320794

Q-STRESS V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320794 ()
419449

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094319057

Software Rest Interp v7.5
WELCH ALLYN, INC.
901155
In Commercial Distribution

  • 00732094319057 ()
107440

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094281385

SOFTWARE Q-STRESS & RSCRIBE V6.2.2
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094281385 ()
11107-005-50

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094272468

SOFTWARE H-SCRIBE VER 4.34
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094272468 ()
11013-018-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272437

SOFTWARE ASSY R-SCRIBE V1.10.10
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094272437 ()
11017-002-50

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094272390

SOFTWARE SURVEYOR IMPORT V4.10
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094272390 ()
11054-009-50

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094272369

SOFTWARE X-SCRIBE HX-GATE V1.11
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272369 ()
11064-003-51

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094326802

E-Scribe Oracle Database Software
WELCH ALLYN, INC.
901134
Not in Commercial Distribution

  • 00732094326802 ()
108086

  • Patient health record information system application software

ARIA - 00885556803868

ARIA HOME PT SOFTWARE
Smith & Nephew, Inc.
SSK1
In Commercial Distribution

  • 00885556803868 ()
SSK1

  • Virtual-display rehabilitation system, non-supportive, clinical

Welch Allyn, Inc. - 00732094356878

DVD SOFTWARE HSCRIBE V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356878 ()
109202

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094356861

DVD SOFTWARE VISION V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356861 ()
109203

  • Electrocardiographic long-term ambulatory recording analyser application software

REAL INTELLIGENCE - 00885556798027

R.I.KNEE 2.1 SOFTWARE KIT
Smith & Nephew, Inc.
ROB10405
In Commercial Distribution

  • 00885556798027 ()
ROB10405

  • Robotic surgical arm system

TriageHF™ - 00763000351656

SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software

StealthStation® Cranial - 00763000253165

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000253165 ()


  • Neurological stereotactic surgery system

Ascom - 17350088671372

TELLIGENCE BRIDGE SOFTWARE V6.4
Ascom (Sweden) AB
NGTELL64-S
In Commercial Distribution

  • 17350088671372 ()


  • Nurse call system

Ascom - 17350088671259

TELLIGENCE BRIDGE SOFTWARE V6.2
Ascom (Sweden) AB
NGTELL62-S
In Commercial Distribution

  • 17350088671259 ()


  • Nurse call system

ASCOM - 17350088671167

TELLIGENCE BRIDGE SOFTWARE V6.1
Ascom (Sweden) AB
NGTELL61-S
In Commercial Distribution

  • 17350088671167 ()


  • Nurse call system

ASCOM - 17350088670368

TELLIGENCE BRIDGE SOFTWARE V4.0
Ascom (Sweden) AB
NGTELL40-S
In Commercial Distribution

  • 17350088670368 ()


  • Nurse call system

Ascom - 17350088671396

TELLIGENCE BRIDGE SOFTWARE V7.0
Ascom (Sweden) AB
NGTELL70-S
In Commercial Distribution

  • 17350088671396 ()


  • Nurse call system

Ascom - 17350088671297

TELLIGENCE BRIDGE SOFTWARE V6.3
Ascom (Sweden) AB
NGTELL63-S
In Commercial Distribution

  • 17350088671297 ()


  • Nurse call system

Ascom - 17350088671266

TELLIGENCE BRIDGE SOFTWARE V5.2
Ascom (Sweden) AB
NGTELL52-S
In Commercial Distribution

  • 17350088671266 ()


  • Nurse call system

Ascom - 17350088670887

TELLIGENCE BRIDGE SOFTWARE V5.3
Ascom (Sweden) AB
NGTELL53-S
In Commercial Distribution

  • 17350088670887 ()


  • Nurse call system

Ascom - 17350088670870

TELLIGENCE BRIDGE SOFTWARE V6.9
Ascom (Sweden) AB
NGTELL69-S
In Commercial Distribution

  • 17350088670870 ()


  • Nurse call system

Ascom - 17350088670825

TELLIGENCE BRIDGE SOFTWARE V6.10
Ascom (Sweden) AB
NGTELL610-S
In Commercial Distribution

  • 17350088670825 ()


  • Nurse call system

Ascom - 17350088670740

TELLIGENCE BRIDGE SOFTWARE V6.8
Ascom (Sweden) AB
NGTELL68-S
In Commercial Distribution

  • 17350088670740 ()


  • Nurse call system

Ascom - 17350088670726

TELLIGENCE BRIDGE SOFTWARE V6.6
Ascom (Sweden) AB
NGTELL66-S
In Commercial Distribution

  • 17350088670726 ()


  • Nurse call system

Ascom - 17350088670719

TELLIGENCE BRIDGE SOFTWARE V6.5
Ascom (Sweden) AB
NGTELL65-S
In Commercial Distribution

  • 17350088670719 ()


  • Nurse call system

Ascom - 17350088670610

TELLIGENCE BRIDGE SOFTWARE V5.1
Ascom (Sweden) AB
NGTELL51-S
Not in Commercial Distribution

  • 17350088670610 ()


  • Nurse call system

Ascom - 17350088670603

TELLIGENCE BRIDGE SOFTWARE V5.0
Ascom (Sweden) AB
NGTELL50-S
Not in Commercial Distribution



  • Nurse call system

Ascom - 17350088670597

TELLIGENCE BRIDGE SOFTWARE V4.1
Ascom (Sweden) AB
NGTELL41-S
In Commercial Distribution



  • Nurse call system

N/A - 04961333236589

COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device

PULSE - 00195377065506

PULSE Software, Base Image
Nuvasive, Inc.
1802489
In Commercial Distribution

  • 00195377065506 ()


  • Orthopaedic stereotactic surgery system

MUSE - 00195278458070

MUSE NX R2 SOFTWARE
Ge Medical Systems Information Technologies, Inc.
NX R2
In Commercial Distribution

  • 00195278458070 ()
4101010-002

  • Cardiology information system application software

Vital Sync - 10884521854260

VITAL SYNC V4 SOFTWARE
Covidien LP
VITALSYNCSW04
In Commercial Distribution

  • 10884521854260 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521849358

VITAL SYNC V4 SOFTWARE
Covidien LP
VITALSYNCSW04
In Commercial Distribution

  • 10884521849358 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521847675

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521847675 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521847569

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521847569 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521845176

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521845176 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521844940

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521844940 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521844933

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521844933 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521835962

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521835962 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521835870

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521835870 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521829855

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521829855 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521829848

VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521829848 ()


  • Multiparameter physiologic analysis workstation

Vital Sync - 10884521823372

VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521823372 ()


  • Multiparameter physiologic analysis workstation
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