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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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X-ray Flat Panel Detector - 06970597830257

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cw
In Commercial Distribution

  • 06970597830257 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detectors - 06970597830172

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cwe
In Commercial Distribution

  • 06970597830172 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830097

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cw
In Commercial Distribution

  • 06970597830097 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830066

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500C
In Commercial Distribution

  • 06970597830066 ()


  • Portable basic diagnostic x-ray system, digital

X-ray Flat Panel Detector - 06970597830035

No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500P
In Commercial Distribution

  • 06970597830035 ()


  • Portable basic diagnostic x-ray system, digital

NA - 00763000871987

CART AFR-00013 SYSTEM US
MEDTRONIC, INC.
AFR-00013
In Commercial Distribution

  • 00763000871987 ()


  • Cardiac mapping system

Affera™ Mapping System - 00763000871956

MAPPING SYSTEM AFR-00003 US
MEDTRONIC, INC.
AFR-00003
In Commercial Distribution

  • 00763000871956 ()


  • Cardiac mapping system

uWS - 06971576834143

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834143 ()


  • MRI system application software

uWS - 06971576834013

MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software

HeartPro - 17540266000029

HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.6
Not in Commercial Distribution

  • 17540266000029 ()


  • MRI system application software

HeartPro - 17540266000012

HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.5
Not in Commercial Distribution

  • 17540266000012 ()


  • MRI system application software

Thermoguide Workstation - 17340007000833

No Description
Clinical Laserthermia Systems AB
1100-N1
In Commercial Distribution

  • 17340007000833 ()


  • MRI system application software

None - 00886874119334

Scroll Wheel
INTUITIVE SURGICAL, INC.
490117
In Commercial Distribution

  • 00886874119334 ()


  • Surgical planning/navigation-enhancement system

None - 00886874119327

Track Ball
INTUITIVE SURGICAL, INC.
490116
In Commercial Distribution

  • 00886874119327 ()


  • Surgical planning/navigation-enhancement system

PlanPoint - 00886874116272

Planning Laptop
INTUITIVE SURGICAL, INC.
380718
In Commercial Distribution

  • 00886874116272 ()


  • Surgical planning/navigation-enhancement system

Comen - 06945429085211

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C60
In Commercial Distribution

  • 06945429085211 ()


  • Multiple vital physiological parameter monitoring system, clinical

Comen - 06945429082548

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C80
In Commercial Distribution

  • 06945429082548 ()


  • Multiple vital physiological parameter monitoring system, clinical

Comen - 06945429055566

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C30
In Commercial Distribution

  • 06945429055566 ()


  • Multiple vital physiological parameter monitoring system, clinical

COMEN - 06945429010053

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C80
In Commercial Distribution

  • 06945429010053 ()


  • Multiple vital physiological parameter monitoring system, clinical

COMEN - 06945429010046

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution

  • 06945429010046 ()


  • Multiple vital physiological parameter monitoring system, clinical

Comen - 06945429000009

No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution

  • 06945429000009 ()


  • Multiple vital physiological parameter monitoring system, clinical

ANKE - 06950743801058

Magnetic Resonance Imaging System, Model: ASM-050P or OPENMARK 5000
Shenzhen Anke High-Tech Co., Ltd.
ASM-050P (OPENMARK 5000)
In Commercial Distribution

  • 06950743801058 ()


  • Full-body MRI system, permanent magnet

NA - 00885554030853

RFB 3RD EDITION 660IMS
Smith & Nephew, Inc.
72200242F3E
In Commercial Distribution

  • 00885554030853 ()
72200242F3E

  • Medical image management system

Patient Information Center IX - 00884838093041

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838093041 ()
866389

  • Centralized patient monitor

Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

N/A - 04961333242573

CBL,4 FIBER LC-LC 75FT
PENTAX OF AMERICA, INC.
92200/75
In Commercial Distribution

  • 04961333242573 ()

  • Length: 75.0 Feet


  • Radiology information system

Harmony Referral System - 06430078740272

No Description
Topcon Healthcare Solutions EMEA Oy
3.10.0
In Commercial Distribution

  • 06430078740272 ()


  • Medical image management system

Fetal Monitor Remote Display - B321340226010

No Description
CLINICOMP INTERNATIONAL, INC.
FMRD 4K 55"
In Commercial Distribution

  • B321340226010 ()

  • Height: 28 Inch
  • Length: 49 Inch
  • Weight: 42 Pound
340-22601

  • Centralized patient monitor

EchoPAC - 00195278951717

MD EchoPAC Plug-In v210
GE Vingmed Ultrasound AS
Plug-In v210
In Commercial Distribution

  • 00195278951717 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278951700

MD EchoPAC Software Only v210
GE Vingmed Ultrasound AS
Software Only v210
In Commercial Distribution

  • 00195278951700 ()


  • Ultrasound imaging system application software

uWS - 06971576834327

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-Angio Basic
In Commercial Distribution

  • 06971576834327 ()


  • Angiographic x-ray system application software

uOmnispace - 06971576834259

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR
In Commercial Distribution

  • 06971576834259 ()


  • MRI system application software

Central Monitoring System - 06944413814264

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

  • 06944413814264 ()
  • 06944413839649 ()


  • Centralized patient monitor

Patient Information Center iX - 00884838048645

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838048645 ()
866389

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094229219

68MCTP VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094229219 ()
  • 00732094151060 ()
68MCTP

  • Multiple vital physiological parameter monitoring system, clinical

Venue Sprint - 00198953001387

Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001387 ()


  • Ultrasound imaging system application software

Ion - 00886874116241

Controller
INTUITIVE SURGICAL, INC.
380707
In Commercial Distribution

  • 00886874116241 ()


  • Surgical planning/navigation-enhancement system

BioJet Target - 04260476810015

Software for biopsy needle guide planning and tracking.
MTT GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software

N/A - 00763000118280

MAPPING SYSTEM CIT200 US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00763000118280 ()


  • Cardiac mapping system

EnSite™ - 05415067053367

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-04
In Commercial Distribution

  • 05415067053367 ()
ENSITE-R-SYS-04

  • Cardiac mapping system

EnSite™ - 05415067053350

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-04
In Commercial Distribution

  • 05415067053350 ()
ENSITE-SYSTEM-04

  • Cardiac mapping system

EnSite™ - 05415067051257

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-04
In Commercial Distribution

  • 05415067051257 ()
ENSITE-DWS-04

  • Cardiac mapping system

EnSite™ - 05415067051226

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-04
In Commercial Distribution

  • 05415067051226 ()
ENSITE-R-DWS-04

  • Cardiac mapping system

Welch Allyn, Inc. - 00732094231014

CIWS WRLS MAS SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094231014 ()
  • 00732094118865 ()
85MXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230901

CIWS STD MAS SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230901 ()
  • 00732094058086 ()
84MXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230888

CIWS STD NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230888 ()
  • 00732094057485 ()
84NXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230857

CIWS WRLS NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230857 ()
  • 00732094118803 ()
85NXVX

  • Multiple vital physiological parameter monitoring system, clinical

Ion - 00886874116234

System Cart
INTUITIVE SURGICAL, INC.
380748
In Commercial Distribution

  • 00886874116234 ()


  • Surgical planning/navigation-enhancement system

HnX-PB - 08800070400166

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-PB
In Commercial Distribution

  • 08800070400166 ()


  • Portable basic diagnostic x-ray system, digital

HnX-P1 - 08800070400074

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-P1
In Commercial Distribution

  • 08800070400074 ()


  • Portable basic diagnostic x-ray system, digital
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