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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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SIUI - 06938396400576

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 2100 Plus
In Commercial Distribution

  • 06938396400576 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396400545

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 5G
In Commercial Distribution

  • 06938396400545 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396400521

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 5T
In Commercial Distribution

  • 06938396400521 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396400484

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius C5
In Commercial Distribution

  • 06938396400484 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396400132

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1G
In Commercial Distribution

  • 06938396400132 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396400125

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1T
In Commercial Distribution

  • 06938396400125 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396400118

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1U
In Commercial Distribution

  • 06938396400118 ()


  • General-purpose ultrasound imaging system

Sepsis ImmunoScore - 00860013516208

No Description
Prenosis, Inc.
1.5.0
In Commercial Distribution

  • 00860013516208 ()


  • Clinical management support software IVD

Bot Image, Inc. - 00860009082625

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software

Bot Image, Inc. - 00860009082618

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
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