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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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COMEN - 06945429010046

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution

  • 06945429010046 ()


  • Multiple vital physiological parameter monitoring system, clinical

Comen - 06945429000009

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution

  • 06945429000009 ()


  • Multiple vital physiological parameter monitoring system, clinical

NA - 00885554030853

RFB 3RD EDITION 660IMS
Smith & Nephew, Inc.
72200242F3E
In Commercial Distribution

  • 00885554030853 ()
72200242F3E

  • Medical image management system

EchoPAC - 00195278951717

MD EchoPAC Plug-In v210
GE Vingmed Ultrasound AS
Plug-In v210
In Commercial Distribution

  • 00195278951717 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278951700

MD EchoPAC Software Only v210
GE Vingmed Ultrasound AS
Software Only v210
In Commercial Distribution

  • 00195278951700 ()


  • Ultrasound imaging system application software

Ion - 00886874116234

System Cart
INTUITIVE SURGICAL, INC.
380748
In Commercial Distribution

  • 00886874116234 ()


  • Surgical planning/navigation-enhancement system

HnX-PB - 08800070400166

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-PB
In Commercial Distribution

  • 08800070400166 ()


  • Portable basic diagnostic x-ray system, digital

HnX-P1 - 08800070400074

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-P1
In Commercial Distribution

  • 08800070400074 ()


  • Portable basic diagnostic x-ray system, digital

OptiMap™ System - NA - 00850064686135

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.
Cortex, Inc.
FG0001-NA
In Commercial Distribution

  • 00850064686135 ()
OPTI-SYS-NA

  • Cardiac mapping system

OptiMap Monitor - 00850064686029

OptiMap Monitor
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system
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