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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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LF - 10746190004813

OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary

LF - 10746190004806

OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


  • CT contrast medium injection system, line-powered, stationary

VITEK® 2 KB UPDATE V2S - 03573026626471

Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.04
In Commercial Distribution

  • 03573026626471 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

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

Cardiostation® Advantage Software - B147CA0

Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution

  • B147CA0 ()


  • Electrocardiography telemetric monitoring system

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

Cardiostation Premier Stand Alone Software - B147CSS0

Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system

CDR DICOM - D764B10301910

CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software

Isolaz - 00816995020615

TIP, PROFUSION, MACH XL WITH SOFTWARE
SOLTA MEDICAL
40-01746
In Commercial Distribution

  • 00816995020615 ()
40-01746

  • Multi-modality skin surface treatment system
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