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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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BD Pyxis - 10885403513770

BD Pyxis Anesthesia Station ES (Software v2.X)
CAREFUSION 303, INC.
SW-PAS-ES-V2
In Commercial Distribution

  • 10885403513770 ()


  • Anaesthesia cabinet

BioPlex 2200 - 03610520540633

BioPlex 2200 System Operation Manual , Software Version 4.3
BIO-RAD LABORATORIES, INC.
SW Version 4.3
In Commercial Distribution

  • 03610520540633 ()

  • 1 EA
12000958

  • Fluorescent immunoassay analyser IVD, laboratory

BioPlex 2200 - 03610520505915

BioPlex 2200 System Operation Manual , Software Version 4.2
BIO-RAD LABORATORIES, INC.
SW Version 4.2
In Commercial Distribution

  • 03610520505915 ()

  • 1 EA
6600813-4.2.1

  • Fluorescent immunoassay analyser IVD, laboratory

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

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

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

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

Naviplan - 07640176970535

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

  • 07640176970535 ()


  • Orthopaedic/craniofacial implantation planning 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

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
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