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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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Xltek - 00382830048293

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

  • 00382830048293 ()


  • Electroencephalograph

Xltek - 00382830048279

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

  • 00382830048279 ()


  • Electroencephalograph

Xltek - 00382830048255

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

  • 00382830048255 ()


  • Electroencephalograph

Xltek - 00382830048231

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

  • 00382830048231 ()


  • Electroencephalograph

N/A - 00613994753106

SOFTWARE 9734587 3D FLUORO CALIBRATION
MEDTRONIC NAVIGATION, INC.
9734587
In Commercial Distribution

  • 00613994753106 ()


  • Multi-purpose stereotactic surgery system

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Kosmos OTS iOS Software Package - 09353278000717

Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software

Kosmos OTS - 09353278000588

Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution

  • 09353278000588 ()


  • Ultrasound imaging system application software

ORTHOMAP - 04546540717450

ORTHOMAP¿ EXPRESS KNEE 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-672-000
In Commercial Distribution

  • 04546540717450 ()
6003-672-000

  • Robotic surgical navigation system application software

ORTHOMAP - 04546540717443

ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-655-000
In Commercial Distribution

  • 04546540717443 ()
6003-655-000

  • Robotic surgical navigation system application software

StealthStation® iNav w/ AxiEM™ TechNology - 00613994231383

SOFTWARE 9733260 AXIEM CRANIAL INAV
MEDTRONIC NAVIGATION, INC.
9733260
In Commercial Distribution

  • 00613994231383 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994377517

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system

AVEA - 10190752159075

KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software

N/A - 00613994422385

SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00613994422385 ()


  • Multi-purpose stereotactic surgery system

Synergy® - 00613994408174

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00613994408174 ()


  • Multi-purpose stereotactic surgery system

Sleepware - 00606959004849

Sleepware G3 Software Package, English
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004849 ()
1082462

  • Polysomnography analyser

HL7 - 00606959048942

Software, HL7 Sleepware G3, Web
Respironics, Inc.
Software, HL7 Sleepware G3, Web - 3
In Commercial Distribution

  • 00606959048942 ()
1117948

  • Clinical laboratory information system

Sleepware - 00606959045279

Software, Sleepware G3, Web download
Respironics, Inc.
Sleepware G3 Software, Web download - 3
In Commercial Distribution

  • 00606959045279 ()
1115720

  • Polysomnography analyser

Actiware - 00606959040366

Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder

Sleepware - 00606959038943

Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser

Sleepware - 00606959046955

Software, Sleepware G3 (Japan Only)
Respironics, Inc.
Sleepware G3 Software, (Japan Only) - 3
Not in Commercial Distribution

  • 00606959046955 ()
1121998

  • Polysomnography analyser

Compumedics Grael - 09342451001313

Grael PSG System, no software
COMPUMEDICS LIMITED
Grael PSG
In Commercial Distribution

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph

Compumedics Grael - 09342451001290

Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph

Compumedics Grael - 09342451001276

Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph

Cochlear - 09321502046503

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1593077
In Commercial Distribution

  • 09321502046503 ()
P1593077

  • Audiometric/hearing device software

Cochlear - 09321502044905

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1348428
In Commercial Distribution

  • 09321502044905 ()
P1348428

  • Audiometric/hearing device software

Cochlear - 09321502044899

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software

Actiware - 00606959057753

Actiware, Software CD, US Gov.
Respironics, Inc.
Actiware, Software CD, US Gov. - 6
In Commercial Distribution

  • 00606959057753 ()
1143911

  • Kinesiology ambulatory recorder

NA - 04931921113080

SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN CORPORATION
QP-260BK
In Commercial Distribution

  • 04931921113080 ()
QP-260BK

  • Evoked-potential graphic recording system

Nihon Kohden Life Scope G7 Bedside Monitoring System - 04931921006689

Software Kit (for CU-171R, CU-172R)
NIHON KOHDEN CORPORATION
QS-127P
In Commercial Distribution

  • 04931921006689 ()
QS-127P

  • General-purpose multi-parameter bedside monitor

Nihon Kohden Life Scope G5 Bedside Monitoring System - 04931921002179

Software Kit (for CU-151R, CU-152R)
NIHON KOHDEN CORPORATION
QS-116P
In Commercial Distribution

  • 04931921002179 ()
QS-116P

  • General-purpose multi-parameter bedside monitor

PREIRUS - 04961333243105

HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
PENTAX OF AMERICA, INC.
HITACHI5.1UPGRD
In Commercial Distribution

  • 04961333243105 ()


  • General-purpose ultrasound imaging system

N/A - 04961333229864

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

  • 04961333229864 ()


  • Electroglottograph

N/A - 04961333229826

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

  • 04961333229826 ()


  • Electroglottograph

MDVP - 04961333229741

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

  • 04961333229741 ()


  • Electroglottograph

NA - 00643169841796

SOFTWARE CD S0278-00 NOAHLINK FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169841796 ()


  • Audiometric/hearing device software

NA - 00643169671553

SOFTWARE CD S0278-00 NOAH FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169671553 ()


  • Audiometric/hearing device software

NA - 00643169693616

SOFTWARE 9735638 FUSION COMPACT ENT
MEDTRONIC NAVIGATION, INC.
9735638
In Commercial Distribution

  • 00643169693616 ()


  • ENT stereotactic surgery system

OMNIBotics - 00841690194712

ART Knee Software unitary component
Omni Life Science, Inc.
0770-2000
In Commercial Distribution

  • 00841690194712 ()
0770-2000

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194460

ART Knee Software Rev 2.4.0
Omni Life Science, Inc.
NS-27014
In Commercial Distribution

  • 00841690194460 ()
NS-27014

  • Robotic surgical navigation system application software
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