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
GE MEDICAL SYSTEMS, INC.
160mm Detector Upgrade
In Commercial Distribution

  • 00840682138796 ()


  • Full-body CT system
No Description
Hangwei GE Medical Systems Co., Ltd.
Frontier
In Commercial Distribution

  • 00840682137553 ()


  • Full-body CT system
No Description
Hangwei GE Medical Systems Co., Ltd.
ACT
In Commercial Distribution

  • 00840682135313 ()


  • Full-body CT system
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134989 ()


  • CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134972 ()


  • CT system application software
No Description
GE MEDICAL SYSTEMS, INC.
Discovery CT A
In Commercial Distribution

  • 00840682125574 ()


  • Full-body CT system
Optima CT520 designated medical device
Hangwei GE Medical Systems Co., Ltd.
CT520
In Commercial Distribution

  • 00840682102568 ()


  • Full-body CT system
No Description
Hangwei GE Medical Systems Co., Ltd.
CT540
In Commercial Distribution

  • 00840682102551 ()


  • Full-body CT system
RT designated medical device
Hangwei GE Medical Systems Co., Ltd.
CT580
In Commercial Distribution

  • 00840682102513 ()


  • Full-body CT system
No Description
GE MEDICAL SYSTEMS, INC.
Discovery CT
In Commercial Distribution

  • 00840682102490 ()


  • Full-body CT system
No Description
BRAINOMIX LIMITED
2.1
In Commercial Distribution

  • B720BX360ELUNG210 ()


  • X-ray image interpretive software
No Description
BRAINOMIX LIMITED
1.0
In Commercial Distribution

  • B720BX360ELUNG100 ()


  • X-ray image interpretive software
Navigation station of the IMACTIS® CT-NAVIGATION system
IMACTIS
J02000
In Commercial Distribution

  • B681J020000 ()
MA-J02000

  • Electromagnetic surgical navigation device tracking system
Transport suitcase for the navigation station of the IMACTIS® CT-NAVIGATION system
IMACTIS
J00197
In Commercial Distribution

  • B681J001971 ()


  • Electromagnetic surgical navigation device tracking system
Power cable of the IMACTIS® CT-NAVIGATION system
IMACTIS
J00099_US
In Commercial Distribution

  • B681J00099US0 ()
MA-J00099_US

  • Electromagnetic surgical navigation device tracking system
Single use Navigation Kit of the IMACTIS® CT-NAVIGATION system
IMACTIS
I10100
In Commercial Distribution

  • B681I101002 ()
MA-I10100

  • Electromagnetic surgical navigation device tracking system
Non-sterile needle holder of the IMACTIS® CT-NAVIGATION system
IMACTIS
A10200
In Commercial Distribution

  • B681A102001 ()


  • Electromagnetic surgical navigation device tracking system
Sterile needle holder of the IMACTIS® CT-NAVIGATION system
IMACTIS
A10010
In Commercial Distribution

  • B681A100101 ()


  • Electromagnetic surgical navigation device tracking system
X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.
CEFLA SOCIETA' COOPERATIVA
NewTom 5G
In Commercial Distribution

  • 08033837931362 ()
P70720000

  • Limited-view-field CT system
Analogic ImpaCT 128-slice
ANALOGIC CORPORATION
10-79245-01
In Commercial Distribution

  • 00814277020308 ()


  • Full-body CT system
Analogic ImpaCT 64-slice
ANALOGIC CORPORATION
10-78480-01
In Commercial Distribution

  • 00814277020162 ()


  • Full-body CT system
Analogic ImpaCT 16-slice
ANALOGIC CORPORATION
10-79182-01
In Commercial Distribution

  • 00814277020155 ()


  • Full-body CT system
No Description
CAScination AG
2.0
In Commercial Distribution

  • 07640167222131 ()


  • Multi-purpose stereotactic surgery system
No Description
CAScination AG
2.0
In Commercial Distribution

  • 17640167220028 ()
  • 07640167220021 ()
50002

  • Surgical optical-tracking spatial marker, single-use
No Description
VERAN MEDICAL TECHNOLOGIES INC.
INS-5925
Not in Commercial Distribution

  • 10815686021310 ()
  • 00815686021313 ()
INS-5925

  • Bronchoscopic catheter
No Description
VERAN MEDICAL TECHNOLOGIES INC.
INS-5920
Not in Commercial Distribution

  • 10815686021303 ()
  • 00815686021306 ()
INS-5920

  • Bronchoscopic catheter
No Description
VERAN MEDICAL TECHNOLOGIES INC.
INS-5915
Not in Commercial Distribution

  • 10815686021297 ()
  • 00815686021290 ()
INS-5915

  • Bronchoscopic catheter
No Description
VERAN MEDICAL TECHNOLOGIES INC.
INS-5912
Not in Commercial Distribution

  • 00815686021283 ()
INS-5912

  • Bronchoscopic catheter
No Description
VERAN MEDICAL TECHNOLOGIES INC.
INS-5910
Not in Commercial Distribution

  • 10815686021273 ()
  • 00815686021276 ()
INS-5910

  • Bronchoscopic catheter
No Description
VERAN MEDICAL TECHNOLOGIES INC.
INS-5905
Not in Commercial Distribution

  • 10815686021266 ()
  • 00815686021269 ()
INS-5905

  • Bronchoscopic catheter
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