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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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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

Lumax™ TS Pro - 00888937013382

Lumax™ TS Pro Advanced Software
Coopersurgical, Inc.
23485
In Commercial Distribution

  • 00888937013382 ()


  • Urodynamic measurement system

Zvu - 00816734022429

Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system

CyberLAB - B433CL0

Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software

360CAS - B432360CAS3110

360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.1
In Commercial Distribution

  • B432360CAS3110 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS3100

360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software

GoCheck Kids - B430GCKNOK44290L

Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera

VITEK® 2 KB UPDATE V2S - 03573026613914

Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.03
In Commercial Distribution

  • 03573026613914 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

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
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