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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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Halo Medical Technologies - 00860008657305

Catalyst Ultrasound System -Portable
Halo Medical Technologies, LLC
HMT-AIOSYS
In Commercial Distribution

  • 00860008657305 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00860008461209

Ultrasonic pulsed doppler imaging system - Convex HD array
Norland at Swissray
uREzpocus C-EMS
In Commercial Distribution

  • 00860008461209 ()


  • General-purpose ultrasound imaging system

Butterfly Network, Inc. - 00866646000206

Portable Ultrasound System
BUTTERFLY NETWORK, INC.
Butterfly iQ
In Commercial Distribution

  • 00866646000206 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396488017

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CTS-8800 Plus
In Commercial Distribution

  • 06938396488017 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396431020

Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CTS-310B
In Commercial Distribution

  • 06938396431020 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396421007

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

  • 06938396421007 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396412005

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1200
In Commercial Distribution

  • 06938396412005 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410094

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000B/W
In Commercial Distribution

  • 06938396410094 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410087

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000Exp
In Commercial Distribution

  • 06938396410087 ()


  • General-purpose ultrasound imaging system

SIUI - 06938396410070

Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000Neo
In Commercial Distribution

  • 06938396410070 ()


  • General-purpose ultrasound imaging system
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