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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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Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

K-ASSAY® Apo AI Reagent - 00816426020016

For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-002
In Commercial Distribution

  • 00816426020016 ()
KAI-002

  • Apolipoprotein A-I (Apo A1) IVD, reagent

ARCHITECT - 00380740019716

Apolipoprotein A1
ABBOTT LABORATORIES
9D92-21
In Commercial Distribution

  • 00380740019716 ()
09D9221

  • Apolipoprotein A-I (Apo A1) IVD, reagent

ARCHITECT - 00380740170141

Apolipoprotein A1 243 Tests
ABBOTT IRELAND
09D9224
In Commercial Distribution

  • 00380740170141 ()
09D9224

  • Apolipoprotein A-I (Apo A1) IVD, reagent

Alinity - 00380740170134

Apolipoprotein A1 190 Tests
ABBOTT IRELAND
09P4624
In Commercial Distribution

  • 00380740170134 ()
09P4624

  • Apolipoprotein A-I (Apo A1) IVD, reagent

iQuest - 00850012642008

AI SaMD for prostate cancer.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution

  • 00850012642008 ()


  • MRI image interpretive software

CEREC - E27665647070

CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software

CEREC - E27665429010

CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
6542901
In Commercial Distribution

  • E27665429010 ()


  • CAD/CAM software

CEREC - E27665347910

CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software

AccuRhythm™ AI - 00763000504519

SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software
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