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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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CENTRICITY - 00840682145794

No Description
GE HEALTHCARE
UNIVERSAL VIEWER 7.0
In Commercial Distribution

  • 00840682145794 ()


  • Medical image management system

CARESCAPE - 00840682144292

V100 GENERIC ATO MODEL No CE
Ge Medical Systems Information Technologies, Inc.
V100
Not in Commercial Distribution

  • 00840682144292 ()


  • Multiple vital physiological parameter monitoring system, clinical

EchoPAC - 00840682141703

No Description
GE Vingmed Ultrasound AS
Software Only v203
In Commercial Distribution

  • 00840682141703 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682141697

No Description
GE Vingmed Ultrasound AS
Plug-in v203
In Commercial Distribution

  • 00840682141697 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682123501

No Description
GE Vingmed Ultrasound AS
Software Only v202
In Commercial Distribution

  • 00840682123501 ()


  • Ultrasound imaging system application software

Bolt Navigation - BN981BN002023

Bolt Navigation Case
Circinus Medical Technology LLC
BN002-02
In Commercial Distribution

  • BN981BN002023 ()
BN002-02

  • Surgical planning/navigation-enhancement system

Bolt Navigation - BN981BN001021

Bolt Navigation Unit, Gen 2.0
Circinus Medical Technology LLC
BN001-02
In Commercial Distribution

  • BN981BN001021 ()
BN001-02

  • Surgical planning/navigation-enhancement system

Bolt Navigation - B981BN00201103

Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution

  • B981BN00201101 ()
  • B981BN00201103 ()
BN002-01-10

  • Surgical planning/navigation-enhancement system

Bolt Navigation - B981BN0010101

Bolt Navigation Unit
Circinus Medical Technology LLC
BN001-01-01
In Commercial Distribution

  • B981BN0010101 ()
BN001-01-01

  • Surgical planning/navigation-enhancement system

FETOLY-HEART - 03770033463000

Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
DIAGNOLY
1
In Commercial Distribution

  • 03770033463000 ()


  • Ultrasound imaging system application software
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