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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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Siesta - 09342451002112

Siesta 802 Basic EEG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic EEG System
In Commercial Distribution

  • 09342451002112 ()
9007-0061-01

  • Electroencephalographic ambulatory recorder

Siesta - 09342451001788

Siesta 802 Basic PSG System w/o Software
Compumedics Usa, Inc.
Siesta 802 Basic PSG System
In Commercial Distribution

  • 09342451001788 ()
9007-0060-00

  • Polysomnograph

Kosmos OTS Android Linear Color - 09353278000694

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007465
In Commercial Distribution

  • 09353278000694 ()


  • Ultrasound imaging system application software

Kosmos OTS Android Linear - 09353278000687

Kosmos on Android software application for ultrasound imaging
ECHONOUS, INC.
P007213
In Commercial Distribution

  • 09353278000687 ()


  • Ultrasound imaging system application software

EchoNous Samsung S8 Tablet with Software (Refurbished) - 09353278000670

EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished)
ECHONOUS, INC.
R007635
In Commercial Distribution

  • 09353278000670 ()


  • Hand-held ultrasound imaging system, body-surface

seca analytics 125 - 04012030022910

Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
In Commercial Distribution

  • 04012030022910 ()
1252000030

  • Medical equipment clinical data interfacing software

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 - 04012030020794

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

  • 04012030020794 ()
1252000012

  • 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

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
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