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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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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

SIUI - 06938396400767

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

  • 06938396400767 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400446

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100S
In Commercial Distribution

  • 06938396400446 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400439

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400422

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400415

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital

Bone Drill - 14719878713112

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-PDL-01
In Commercial Distribution

  • 14719878713112 ()


  • Surgical planning/navigation-enhancement system

Minimally Invasive Spine Surgery Instruments - 14719878713099

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-02
In Commercial Distribution

  • 14719878713099 ()


  • Surgical planning/navigation-enhancement system

Central Monitoring System - 06944413800229

No Description
Edan Instruments, Inc.
MFM-CMS
In Commercial Distribution

  • 06944413800229 ()


  • Centralized patient monitor

Care Assist - 00884838127449

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist Android
In Commercial Distribution

  • 00884838127449 ()
989803221541

  • Centralized patient monitor

Care Assist - 00884838127432

Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
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