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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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UNITRON - 07613389221589

TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software

UNITRON - 07613389221572

TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software

HANSATON - 07613389143232

USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software

HANSATON - 07613389143225

DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE - B1623181

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct

AirStrip OB Legacy iOS - B15310010

OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter

AirStrip OB Legacy Server - B15310000

OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter

Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle - 00817980020283

ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Vita CR System - 60889971919878

IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner

n.a. - 04048551228517

KARL STORZ SCB Software Upgrade "VOICE1"
Karl Storz GmbH & Co. KG
20090001-40
In Commercial Distribution

  • 04048551228517 ()


  • Operating room audiovisual data/device management system application software
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