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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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4Klearity - 00817613021021

4Klearity Med X Change Brand Software Version 7.12.1.2
Nds Surgical Imaging LLC
4KR100
Not in Commercial Distribution

  • 00817613021021 ()


  • Endoscopic video image processing unit

Earlens Wireless Updater - 08500130070000

Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit

FONA CDR DICOM - D764B10351060

FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
SIRONA DENTAL, INC.
B1035106
In Commercial Distribution

  • D764B10351060 ()


  • Diagnostic x-ray digital imaging system workstation application software

GoCheck Kids - B430GCKNOK44360

GoCheck Kids stand-alone software for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.36
In Commercial Distribution

  • B430GCKNOK44360 ()


  • External ocular measurement camera

Naviplan - 07640176970535

NAVIPLAN, CT Planning Software for Total Hip Replacement
Naviswiss AG
NS053
In Commercial Distribution

  • 07640176970535 ()


  • Orthopaedic/craniofacial implantation planning software

VIDAS® PC SOFTWARE V4.9 - 03573026619527

VIDAS PC V4.9 W10 Software version for clinic
BIOMERIEUX SA
4.9
In Commercial Distribution

  • 03573026619527 ()


  • Fluorescent immunoassay analyser IVD, laboratory

Vasomedical-Biox™ ARCS ABP Analysis & Reporting S/W & Dongle w/Bluetooth - 00817980020290

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

  • 00817980020290 ()
A10-0118-60

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG - 00817980020146

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

  • 00817980020146 ()
A10-0032

  • Electrocardiographic long-term ambulatory recording analyser application software

Natus - 00382830045070

EMG v22 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630300
In Commercial Distribution

  • 00382830045070 ()


  • Electromyograph

FACS - 00382906577658

BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD
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