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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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QVCAD System - B630QVCS342

No Description
QVIEW MEDICAL
3.4.2
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS33

No Description
QVIEW MEDICAL
3.3
In Commercial Distribution

  • B630QVCS33 ()


  • Ultrasound imaging system application software

Mediblu - B632MDB01035

No Description
MEDIBLU MEDICAL LLC
Blu15+
In Commercial Distribution

  • B632MDB01035 ()
MDB01035

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01034

No Description
MEDIBLU MEDICAL LLC
BLU 12+
In Commercial Distribution

  • B632MDB01034 ()
MDB01034

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01028

No Description
MEDIBLU MEDICAL LLC
BLU 12
In Commercial Distribution

  • B632MDB01028 ()
MDB01028

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01004

No Description
MEDIBLU MEDICAL LLC
MM5
In Commercial Distribution

  • B632MDB01004 ()
MDB01004

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01001

No Description
MEDIBLU MEDICAL LLC
MM17
In Commercial Distribution

  • B632MDB01001 ()
MDB01001

  • Multiple vital physiological parameter monitoring system, clinical

QVCAD System - B630QVCS34

No Description
QVIEW MEDICAL
3.4
In Commercial Distribution



  • Ultrasound imaging system application software

Omni™ Surgical Suite Platform - 00889024647343

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024647343 ()
AI1000

  • Medical image management system

Visualize:Vascular - B725INITVV12

Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software

Triworks Group srl - 08057168020083

Nitrogen Plasma system
TRIWORKS GROUP SRL
PurePlasma
In Commercial Distribution

  • 08057168020083 ()


  • Nitrogen plasma skin surface treatment system

Triworks Group srl - 08057168020007

Plasma device
TRIWORKS GROUP SRL
AgeJet
In Commercial Distribution

  • 08057168020007 ()


  • Nitrogen plasma skin surface treatment system

Venue Sprint - 00195278754011

Venue Sprint R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278754011 ()


  • Ultrasound imaging system application software

Vscan - 00195278884749

Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software

Vscan - 00195278884725

Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software

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

SMARTSCREEN - 04048551418147

OR1 SmartScreen
Karl Storz GmbH & Co. KG
WM200
In Commercial Distribution

  • 04048551418147 ()


  • Physician-practice-management information system

n.a. - 04048551415320

KARL STORZ AIDA
Karl Storz GmbH & Co. KG
WD300
In Commercial Distribution

  • 04048551415320 ()
WD300

  • Physician-practice-management information system

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

Mobile Care - 00840682106498

No Description
GE Healthcare Finland Oy
Web Viewer
In Commercial Distribution

  • 00840682106498 ()


  • Centralized patient monitor

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

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

EchoPAC - 00840682103961

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

  • 00840682103961 ()


  • Ultrasound imaging system application software

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

CENTRICITY - 00840682145794

No Description
GE HEALTHCARE
UNIVERSAL VIEWER 7.0
In Commercial Distribution

  • 00840682145794 ()


  • Medical image management system

EchoPAC - 00840682141703

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

  • 00840682141703 ()


  • 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

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 - 00840682141697

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

  • 00840682141697 ()


  • Ultrasound imaging system application software

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

Vmax - 10846446032918

SWR KIT CARDIOSOFT V6.73
Carefusion Corporation
28282-001
Not in Commercial Distribution

  • 10846446032918 ()
28282-001

  • Cardiac mapping system

Vmax - 10846446032901

SWR PKG CARDIOSOFT V6.73
Carefusion Corporation
28281-001
Not in Commercial Distribution

  • 10846446032901 ()
28281-001

  • Cardiac mapping system

Vmax - 10846446032888

CARDIOSOFT V6.73 CAM14 W/USB
Carefusion Corporation
28278-001
Not in Commercial Distribution

  • 10846446032888 ()
28278-001

  • Cardiac mapping system

OPAL HDx™ - 00191506055370

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system

OPAL HDx™ - 00191506055325

Mapping System Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system
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