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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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seca analytics 125 - 04012030021678

Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030021678 ()
1252000020

  • Medical equipment clinical data interfacing software

seca analytics 125 - 04012030020503

Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030020503 ()
1252000010

  • Medical equipment clinical data interfacing 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

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

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

Lumax - 60888937013452

Lumax™ TS Pro • EMG Software Upgrade Kit
Coopersurgical, Inc.
53366
In Commercial Distribution

  • 60888937013452 ()


  • Urodynamic measurement system

Aurora Xi - 00810020442199

Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020441192

Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.122.0
In Commercial Distribution

  • 00810020441192 ()


  • Apheresis system
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