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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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Vasomedical-Biox™ ARCS Analysis & Reporting Software Dongle Only, 3 CH ECG - 00817980020207

ARCS Analysis & Reporting Software Dongle Only, 3 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020207 ()
A10-0118-02

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USB - 00817980020177

ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020177 ()
A10-0118-00

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 & 12 CH ECG - 00817980020139

CB Series Analysis & Reporting Software - 3 & 12 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020139 ()
A10-0031

  • Electrocardiographic long-term ambulatory recording analyser application software

SOZOpro - B277SOZOPRO0

Application- Bio-Impendence Analysis software used for determining Body Composition
IMPEDIMED LIMITED
1.1.0
Not in Commercial Distribution

  • B277SOZOPRO0 ()
SOZOpro

  • Bioelectrical body composition analyser

Sherlock - 00801741121470

Sherlock 3GC Diamond TCS on Site~Rite 8 Software
Bard Access Systems, Inc.
Sherlockv1.1.2
In Commercial Distribution

  • 00801741121470 ()
Sherlockv1.1.2

  • Central venous catheter navigation system, electrocardiographic/magnetic

MicronMapper - 07540209956232

Software for MicronMapper and MicronMapper EVO Dental Metrology Systems
Claronav Inc
990-MM1-INST-WIN
In Commercial Distribution

  • 07540209956232 ()


  • Dental milling system, CAD/CAM, laboratory

Bausch + Lomb - 00757770524532

Stellaris Elite PC with Laser with Version 5+ Software
Bausch & Lomb Incorporated
BL15455
In Commercial Distribution

  • 00757770524532 ()
BL15455

  • Phacoemulsification/vitrectomy system

Bausch + Lomb - 00757770524525

Stellairs Elite PC Combined System with Version 5+ Software
Bausch & Lomb Incorporated
BL14455
In Commercial Distribution

  • 00757770524525 ()
BL14455

  • Phacoemulsification/vitrectomy system

EchoGo - 05060634690065

No Description
ULTROMICS LIMITED
Amyloidosis 1.0
In Commercial Distribution

  • 05060634690065 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690058

No Description
ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
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