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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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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

CARESCAPE Central Station - 00840682109604

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

  • 00840682109604 ()


  • Centralized patient monitor

EchoPAC - 00840682104333

No Description
GE Vingmed Ultrasound AS
Plug-in v201
In Commercial Distribution

  • 00840682104333 ()


  • Ultrasound imaging system application software

NOGA XP - 10846835011678

NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution

  • 10846835011678 ()
FG170000

  • Cardiac mapping system

CARTO 3 - 10846835000870

CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system

Optima - 00840682115278

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

  • 00840682115278 ()


  • Portable basic diagnostic x-ray system, digital

Mobile Care - 00840682106498

No Description
GE Healthcare Finland Oy
Web Viewer
In Commercial Distribution

  • 00840682106498 ()


  • Centralized patient monitor

EchoPAC - 00840682103961

No Description
GE Vingmed Ultrasound AS
Software Only v201
In Commercial Distribution

  • 00840682103961 ()


  • Ultrasound imaging system application software

CENTRICITY - 00840682103800

No Description
GE HEALTHCARE
UNIVERSAL VIEWER 6.0
In Commercial Distribution

  • 00840682103800 ()


  • Medical image management system

CARESCAPE - 00840682103091

V100 GENERIC ATO MODEL
Ge Medical Systems Information Technologies, Inc.
V100
In Commercial Distribution

  • 00840682103091 ()


  • Multiple vital physiological parameter monitoring system, clinical

CENTRICITY - 00840682102988

No Description
GE HEALTHCARE
UNIVERSAL VIEWER ZFP CLIENT 6.0
In Commercial Distribution

  • 00840682102988 ()


  • Medical image management system

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

Vscan - 00840682147101

Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software

Vscan - 00840682147071

Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682146883

No Description
GE Vingmed Ultrasound AS
Software Only v204
In Commercial Distribution

  • 00840682146883 ()


  • Ultrasound imaging system application software

EchoPAC - 00840682146876

No Description
GE Vingmed Ultrasound AS
Plug-in v204
In Commercial Distribution

  • 00840682146876 ()


  • Ultrasound imaging system application software

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

qube mini - 10841522131462

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
In Commercial Distribution

  • 10841522131462 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522131141

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522131141 ()

  • 21.5"
011-0262-00

  • Centralized patient monitor

Xhibit - 10841522129780

DISPLAY,21.5",CAPACITIVE TOUCH,BLACK, ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522129780 ()
011-0241-02

  • Centralized patient monitor

PlaDuo System - 08800017100159

No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017100159 ()


  • Nitrogen plasma skin surface treatment system

BEWELL CONNECT MyECG - 03760165449270

No Description
VISIOMED GROUP
BW-HR1
In Commercial Distribution

  • 03760165449270 ()


  • Cardiac mapping system

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

B-Right Screen Fetal Heart - 03760415600000

Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution

  • 03760415600000 ()


  • Ultrasound imaging system application software
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