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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No Description
ICU MEDICAL, INC.
1102P
In Commercial Distribution

  • 35019517053924 ()
  • 15019517053920 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
1101A
In Commercial Distribution

  • 35019517053894 ()
  • 15019517053890 ()


  • Multiple vital physiological parameter monitoring system, clinical
Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100027 ()


  • MRI system application software
No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system
No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system
No Description
ICU MEDICAL, INC.
WW3078
In Commercial Distribution

  • 30843418001099 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cwe
In Commercial Distribution

  • 06970597830745 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750Cw
In Commercial Distribution

  • 06970597830363 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750C
In Commercial Distribution

  • 06970597830349 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cw
In Commercial Distribution

  • 06970597830257 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cwe
In Commercial Distribution

  • 06970597830172 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cw
In Commercial Distribution

  • 06970597830097 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500C
In Commercial Distribution

  • 06970597830066 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500P
In Commercial Distribution

  • 06970597830035 ()


  • Portable basic diagnostic x-ray system, digital
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
Scroll Wheel
INTUITIVE SURGICAL, INC.
490117
In Commercial Distribution

  • 00886874119334 ()


  • Surgical planning/navigation-enhancement system
Track Ball
INTUITIVE SURGICAL, INC.
490116
In Commercial Distribution

  • 00886874119327 ()


  • Surgical planning/navigation-enhancement system
Planning Laptop
INTUITIVE SURGICAL, INC.
380718
In Commercial Distribution

  • 00886874116272 ()


  • Surgical planning/navigation-enhancement system
No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C60
In Commercial Distribution

  • 06945429085211 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C80
In Commercial Distribution

  • 06945429082548 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C30
In Commercial Distribution

  • 06945429055566 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C80
In Commercial Distribution

  • 06945429010053 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution

  • 06945429010046 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Shenzhen Comen Medical Instruments Co., Ltd.
C50
In Commercial Distribution

  • 06945429000009 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-Angio Basic
In Commercial Distribution

  • 06971576834327 ()


  • Angiographic x-ray system application software
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR
In Commercial Distribution

  • 06971576834259 ()


  • MRI system application software
No Description
Edan Instruments, Inc.
MFM-CMS
In Commercial Distribution

  • 06944413814264 ()
  • 06944413839649 ()


  • Centralized patient monitor
No Description
Topcon Healthcare Solutions EMEA Oy
3.10.0
In Commercial Distribution

  • 06430078740272 ()


  • Medical image management system
Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838048645 ()
866389

  • Centralized patient monitor
Software for biopsy needle guide planning and tracking.
MTT GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software
MAPPING SYSTEM CIT200 US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00763000118280 ()


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

  • 04961333242573 ()

  • Length: 75.0 Feet


  • Radiology information system
Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838093041 ()
866389

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

  • 00198953030233 ()


  • Ultrasound imaging system application software
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
Controller
INTUITIVE SURGICAL, INC.
380707
In Commercial Distribution

  • 00886874116241 ()


  • Surgical planning/navigation-enhancement system
Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001387 ()


  • Ultrasound imaging system application software
68MCTP VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094229219 ()
  • 00732094151060 ()
68MCTP

  • Multiple vital physiological parameter monitoring system, clinical
RFB 3RD EDITION 660IMS
Smith & Nephew, Inc.
72200242F3E
In Commercial Distribution

  • 00885554030853 ()
72200242F3E

  • Medical image management system
System Cart
INTUITIVE SURGICAL, INC.
380748
In Commercial Distribution

  • 00886874116234 ()


  • Surgical planning/navigation-enhancement system
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