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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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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

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

NA - 00840682124591

MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software

EchoPAC - 00840682123518

No Description
GE Vingmed Ultrasound AS
Plug-in v202
In Commercial Distribution

  • 00840682123518 ()


  • 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

EchoPAC - 00840682121095

No Description
GE Vingmed Ultrasound AS
Software Only v113
In Commercial Distribution

  • 00840682121095 ()


  • Ultrasound imaging system application software

DaTQUANT - 00840682119306

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
1.0
In Commercial Distribution

  • 00840682119306 ()


  • SPECT system application software

CARESCAPE - 00840682117722

No Description
Innokas Yhtymä Oy
VC150
In Commercial Distribution

  • 00840682117722 ()


  • Multiple vital physiological parameter monitoring system, clinical

Optima - 00840682115278

No Description
GE MEDICAL SYSTEMS, INC.
XR200amx
In Commercial Distribution

  • 00840682115278 ()


  • 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
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