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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

Natus - 00382830038027

Synergy EDX Application Software CD
NATUS NEUROLOGY INCORPORATED
482-645900
In Commercial Distribution

  • 00382830038027 ()


  • Electromyograph

Natus - 00382830036160

EMG Software Upgrade to v22.4
NATUS NEUROLOGY INCORPORATED
688-628500
In Commercial Distribution

  • 00382830036160 ()


  • Electromyograph

Natus - 00382830036153

EMG Software Update to v22.3
NATUS NEUROLOGY INCORPORATED
688-628600
In Commercial Distribution

  • 00382830036153 ()


  • Electromyograph

Natus - 00382830035033

Natus Elite - Synergy Master Software
NATUS NEUROLOGY INCORPORATED
828-069300
In Commercial Distribution

  • 00382830035033 ()


  • Electromyograph

Natus - 00382830035026

Natus Elite - Viking Master Software
NATUS NEUROLOGY INCORPORATED
828-069400
In Commercial Distribution

  • 00382830035026 ()


  • Electromyograph

Natus - 00382830022309

Neuroworks/Sleepworks 8.1.0 (International) software
XLTEK
015418
In Commercial Distribution

  • 00382830022309 ()


  • Electroencephalograph

Natus - 00382830037969

EMG v21.1.0 Application Software CD
NATUS NEUROLOGY INCORPORATED
482-651200
In Commercial Distribution

  • 00382830037969 ()


  • Electromyograph

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 - 00606959045279

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

  • 00606959045279 ()
1115720

  • Polysomnography analyser

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

Sleepware - 00606959004849

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

  • 00606959004849 ()
1082462

  • Polysomnography analyser

EX-M1 - 04547410448214

A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system

IEM GmbH - 04041346102207

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.3.x
In Commercial Distribution

  • 04041346102207 ()


  • Medical equipment clinical data interfacing software

IEM GmbH - 04041346102153

Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.2.x
Not in Commercial Distribution

  • 04041346102153 ()


  • Medical equipment clinical data interfacing software
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