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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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CRW® - 10381780252658

ATLASPLAN Software
INTEGRA LIFESCIENCES CORPORATION
ATLASSW
Not in Commercial Distribution

  • M248ATLASSW1 ()
  • 10381780252658 ()


  • Neurological stereotactic surgery system

Gendex VixWin™ imaging software - EKAV101037680

Imaging software
GENDEX CORP.
3
In Commercial Distribution

  • EKAV101037680 ()
VIXWINPL

  • Radiology information system application software

VisionX - E247E7300

Dental Imaging Software. Software Version 2.x.x.
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300 ()


  • General-purpose dental x-ray system application software

DBSWIN - E247E7200A0

Dental Imaging Software. Software Version 5.x.x.
DÜRR DENTAL SE
E7200A
Not in Commercial Distribution

  • E247E7200A0 ()


  • General-purpose dental x-ray system application software

NeuroSENSE - B746NS90101

No Description
Neurowave Systems Inc.
NS-901
In Commercial Distribution

  • B746NS90101 ()


  • Anaesthesia depth monitor

MAXUM - M737M61021

Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system

UbiqVue - B353UA2550S1

Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution

  • B353UA2550S1 ()


  • Network server

UbiqVue - B353UA2550RB1

Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution

  • B353UA2550RB1 ()


  • Physiological measuring device wireless data capture/transfer unit

UbiqVue - B353UA2550BG1

Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution

  • B353UA2550BG1 ()


  • Physiological measuring device wireless data capture/transfer unit

XDR - D787XDRSW300

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software
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