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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 - 06938396423018

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution

  • 06938396423018 ()


  • Portable basic diagnostic x-ray system, digital

Empatica Health Monitoring Platform - 00853858006263

No Description
EMPATICA SRL
Care Portal
In Commercial Distribution

  • 00853858006263 ()


  • Multiple vital physiological parameter monitoring system, home-use

Empatica Health Monitoring Platform - 00853858006256

No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use

Empatica Health Monitoring Platform - 00853858006249

No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use

Empatica Health Monitoring Platform - 00853858006232

No Description
EMPATICA SRL
EmbracePlus
In Commercial Distribution

  • 00853858006232 ()
EMBP-CC-MS

  • Multiple vital physiological parameter monitoring system, home-use

Augmented Reality Application - G67910

No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system

CLAROX plus - 08800124900017

VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution

  • 18800124900014 ()
  • 08800124900017 ()


  • Portable basic diagnostic x-ray system, digital

CARESCAPE - 00840682109833

CARESCAPE CENTRAL STATION V1 UPGRADE KIT FROM CIC V5 ON MP100
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1 upgrade
Not in Commercial Distribution

  • 00840682109833 ()


  • Centralized patient monitor

CARESCAPE - 00840682109826

ASSY CSCS V1 MP100D DESKTOP
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1
Not in Commercial Distribution

  • 00840682109826 ()


  • Centralized patient monitor

CARESCAPE Central Station - 00840682109666

CARESCAPE CENTRAL STATION V2 MAI 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Integrated MAI 700
Not in Commercial Distribution

  • 00840682109666 ()


  • Centralized patient monitor
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