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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NEUWAVE AC System - 120V
NEUWAVE MEDICAL, INC.
2.45 GHz Ablation System
Not in Commercial Distribution

  • 00853719006180 ()
DR-000783

  • Microwave ablation system generator
No Description
GE HEALTHCARE JAPAN CORPORATION
CT660 Cj2.5 Upgrade
In Commercial Distribution

  • 00840682116510 ()


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

  • 00840682109796 ()


  • 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
Planning Station
Covidien LP
AED00172-30
In Commercial Distribution

  • 10884521545588 ()


  • Portable computer
Firm Tip;Endobronchial Procedure Kit;90 Catheter
Covidien LP
SDK4900-FT
In Commercial Distribution

  • 10884521545571 ()

  • Second Outer Diameter,2.0,Millimeter;
  • Outer Diameter: 2.68 Millimeter
  • Length: 1069.5 Millimeter


  • Bronchoscopic catheter
Firm Tip; Endobronchial Procedure Kit;45 Catheter
Covidien LP
SDK4450-FT
In Commercial Distribution

  • 10884521545564 ()

  • Outer Diameter: 2.68 Millimeter
  • Length: 1069.5 Millimeter
  • Second Outer Diameter,2.0,Millimeter;


  • Bronchoscopic catheter
Firm Tip;Endobronchial Procedure Kit;180 Catheter
Covidien LP
SDK4000-FT
In Commercial Distribution

  • 10884521545557 ()

  • Outer Diameter: 2.68 Millimeter
  • Length: 1069.5 Millimeter
  • Second Outer Diameter,2.0,Millimeter;


  • Bronchoscopic catheter
Bronchoscope Adapter;For use with Olympus 190 bronchoscopes
Covidien LP
SD303BAPK
In Commercial Distribution

  • 20884521539775 ()
  • 10884521539778 ()


  • Endoscope working-channel valve, single-use
Bronchoscope Adapter;For use with Fujinon bronchoscopes
Covidien LP
SD302BAPK
In Commercial Distribution

  • 20884521539768 ()
  • 10884521539761 ()


  • Endoscope working-channel valve, single-use
Bronchoscope Adapter;For use with Pentax bronchoscopes
Covidien LP
SD301BAPK
In Commercial Distribution

  • 20884521539751 ()
  • 10884521539754 ()


  • Endoscope working-channel valve, single-use
Bronchoscope Adapter;For use with Olympus bronchoscopes
Covidien LP
SD300BAPK
In Commercial Distribution

  • 20884521539744 ()
  • 10884521539747 ()


  • Endoscope working-channel valve, single-use
Fiducial Marker;Nitinol Coil
Covidien LP
SDGN447
In Commercial Distribution

  • 20884521539706 ()
  • 10884521539709 ()

  • Width: 4 Millimeter
  • Length: 7 Millimeter


  • Radiological image marker, implantable
Marker Delivery Kit
Covidien LP
SDMDK1000
In Commercial Distribution

  • 20884521809564 ()
  • 10884521809567 ()

  • Length: 125 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 0.038 Inch


  • Bronchoscopic catheter
Patient Sensor Patch
Covidien LP
AKI00131-01
In Commercial Distribution

  • 20884521807973 ()
  • 10884521807976 ()


  • Multi-purpose surgical skin adhesive tape
navigation system console
Covidien LP
AAS00161-20
In Commercial Distribution

  • 10884521806153 ()
AAS00161-20

  • Electromagnetic surgical navigation device tracking system
Procedure Software V1.0
Covidien LP
Procedure Application V1.0
In Commercial Distribution

  • 10884521779983 ()


  • Electromagnetic surgical navigation device tracking system
Fiducial Marker;Nitinol Coil
Covidien LP
SDGN447
In Commercial Distribution

  • 20884521762685 ()
  • 10884521762688 ()

  • Width: 4.0 Millimeter
  • Length: 7.0 Millimeter


  • Radiological image marker, implantable
v7.1 Planning Software
Covidien LP
PMB00569-01
In Commercial Distribution

  • 10884521747432 ()


  • Electromagnetic surgical navigation device tracking system
v7.2 upgrade kit
Covidien LP
ILS-0001-FN
In Commercial Distribution

  • 10884521747418 ()


  • Electromagnetic surgical navigation device tracking system
Patient Sensor Patches
Covidien LP
ILS-1000-SP
In Commercial Distribution

  • 20884521842424 ()
  • 10884521807983 ()


  • Multi-purpose surgical skin adhesive tape
superDimension Planning Station
Covidien LP
ILS-0726-PS
In Commercial Distribution

  • 10884521785861 ()


  • Portable computer
Planning Software V1.0
Covidien LP
Planning Application V1.0
In Commercial Distribution

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking system
v7.2 Procedure Software
Covidien LP
PMB00667-01
In Commercial Distribution

  • 10884521747425 ()


  • Electromagnetic surgical navigation device tracking system
Bronchoscope Adapter for se with Fujinon bronchoscopes
Covidien LP
ILS-2300-PK
In Commercial Distribution

  • 10884521723993 ()
  • 20884521723990 ()


  • Endoscope working-channel valve, single-use
Bronchoscope Adapter for use with Pentax bronchoscopes
Covidien LP
ILS-2200-PK
In Commercial Distribution

  • 10884521723986 ()
  • 20884521723983 ()


  • Endoscope working-channel valve, single-use
Bronchocope Adapter for use with Olyumpus 190 bronchoscope
Covidien LP
ILS-2100-PK
In Commercial Distribution

  • 10884521723979 ()
  • 20884521723976 ()


  • Endoscope working-channel valve, single-use
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