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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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MediGuide™ - 05415067013002

System Installation Tool
ST. JUDE MEDICAL, INC.
100096650
In Commercial Distribution

  • 05415067013002 ()
100096650

  • Cardiac mapping system

MediGuide™ - 05415067012586

Cable Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067012586 ()
H701258

  • Cardiac mapping system

MediGuide™ - 05415067012579

Cable Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067012579 ()
H701257

  • Cardiac mapping system

MediGuide™ - 05415067012562

Cable Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067012562 ()
H701256

  • Cardiac mapping system

MediGuide™ - 05415067012555

Cable Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067012555 ()
H701255

  • Cardiac mapping system

MediGuide™ - 05415067012135

Upgrade Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067012135 ()
H701213

  • Cardiac mapping system

MediGuide™ - 05415067010995

ECG Cable
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067010995 ()
H701099

  • Cardiac mapping system

MediGuide™ - 05415067010933

Cover Proximity Switch
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067010933 ()
H701093

  • Cardiac mapping system

MediGuide™ - 05415067023711

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023711 ()
MG1000

  • Cardiac mapping system

MediGuide™ - 05415067020512

VD10 Compatible System
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067020512 ()
MG1000

  • Cardiac mapping system

MediGuide™ - 05415067020475

System
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067020475 ()
MG1000

  • Cardiac mapping system

MediGuide™ - 05415067020468

System
ST. JUDE MEDICAL, INC.
MG1000
In Commercial Distribution

  • 05415067020468 ()
MG1000

  • Cardiac mapping system

EnSite™ - 05415067048721

X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

  • Cardiac mapping system

EnSite™ - 05415067046710

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-2.0.1
In Commercial Distribution

  • 05415067046710 ()
ENSITE-DWS-2.0.1

  • Cardiac mapping system

EnSite™ - 05415067046697

X EP System EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system

EnSite™ - 05415067046680

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-2.0.1
In Commercial Distribution

  • 05415067046680 ()
ENSITE-R-DWS-2.0.1

  • Cardiac mapping system

EnSite™ - 05415067046666

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system

EnSite™ - 05415067041722

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system

EnSite™ - 05415067037756

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-1.1
In Commercial Distribution

  • 05415067037756 ()
ENSITE-R-DWS-1.1

  • Cardiac mapping system

EnSite™ - 05415067034755

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-02
In Commercial Distribution

  • 05415067034755 ()
ENSITE-AMP-02

  • Cardiac mapping system

EnSite™ - 05415067034748

X EP System Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-02
In Commercial Distribution

  • 05415067034748 ()
ENSITE-R-AMP-02

  • Cardiac mapping system

EnSite™ - 05415067032188

Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032171

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-01
In Commercial Distribution

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032164

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system

EnSite™ - 05415067032157

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system

EnSite™ - 05415067037725

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-1.1
In Commercial Distribution

  • 05415067037725 ()
ENSITE-DWS-1.1

  • Cardiac mapping system

EnSite™ - 05415067051165

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system

EnSite™ - 05415067051141

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051134

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051127

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system

Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300) - 08809988780001

No Description
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use

Remidio - 08906096520069

Remidio Connect is web-based application it is intended for displaying, storing images and data from Remidio ophthalmic imaging devices to aid in screening of eye disease.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Remidio Connect
In Commercial Distribution

  • 08906096520069 ()


  • Medical image management system

FUKUDA DENSHI - 04538612915840

No Description
FUKUDA DENSHI CO.,LTD.
DS-1812
In Commercial Distribution

  • 04538612915840 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612915826

No Description
FUKUDA DENSHI CO.,LTD.
DS-1800L
In Commercial Distribution

  • 04538612915826 ()


  • Centralized patient monitor

FUKUDA DENSHI - 04538612912061

No Description
FUKUDA DENSHI CO.,LTD.
LC-8026T
In Commercial Distribution

  • 04538612912061 ()


  • Centralized patient monitor

Harmony Referral System - 06430078740265

No Description
Topcon Healthcare Solutions EMEA Oy
3.9.1
In Commercial Distribution

  • 06430078740265 ()


  • Medical image management system

Harmony Referral System - 06430078740005

Harmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience.
Topcon Healthcare Solutions EMEA Oy
3.8.1
In Commercial Distribution

  • 06430078740005 ()


  • Medical image management system

SIUI - 06938396423025

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300S
In Commercial Distribution

  • 06938396423025 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396410063

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000S
In Commercial Distribution

  • 06938396410063 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396410049

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000
In Commercial Distribution

  • 06938396410049 ()


  • Portable basic diagnostic x-ray system, digital
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