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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Plasma device
TRIWORKS GROUP SRL
AgeJet
In Commercial Distribution

  • 08057168020007 ()


  • Nitrogen plasma skin surface treatment system
No Description
Sleepiz AG
1.0
In Commercial Distribution

  • 07649996477019 ()


  • Multiple vital physiological parameter monitoring system, home-use
Monitor with DOX SPO2, NIBP, and HR
CRITICARE TECHNOLOGIES, INC.
eQuality 506DN
In Commercial Distribution

  • B438560DNUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical
Synergy Matrix Management SW Addtnl Lic
ARTHREX, INC.
AR-3200-1049
In Commercial Distribution

  • 00888867261648 ()
AR-3200-1049

  • Medical image management system
Synergy.Net Text Notification License K
ARTHREX, INC.
AR-3200-1046
In Commercial Distribution

  • 00888867200319 ()
AR-3200-1046

  • Medical image management system
Synergy.Net Reporting License Key
ARTHREX, INC.
AR-3200-1045
In Commercial Distribution

  • 00888867200302 ()
AR-3200-1045

  • Medical image management system
Synergy.Net OR Command License Key
ARTHREX, INC.
AR-3200-1044
In Commercial Distribution

  • 00888867200296 ()
AR-3200-1044

  • Medical image management system
Synergy.net Printing License Key
ARTHREX, INC.
AR-3200-1043
In Commercial Distribution

  • 00888867200289 ()
AR-3200-1043

  • Medical image management system
RhythmView Workstation, US, streaming, refurbished
ABBOTT
2002-R
Not in Commercial Distribution

  • 00810591020185 ()
2002-R

  • Cardiac mapping system
RhythmView Workstation, US, refurbished
ABBOTT
2000-R
In Commercial Distribution

  • 00810591020161 ()
2000-R

  • Cardiac mapping system
USB Memory Stick
ABBOTT
USB-MEMSTK
In Commercial Distribution

  • 30810591020155 ()
  • 00810591020154 ()
USB-MEMSTK

  • Cardiac mapping system
RhythmView Workstation, US, Streaming
ABBOTT
2002
Not in Commercial Distribution

  • 00810591020130 ()
2002

  • Cardiac mapping system
RhythmView Workstation, US
ABBOTT
2000
In Commercial Distribution

  • 00810591020116 ()
2000

  • Cardiac mapping system
Assembly, Solid State Drive
ABBOTT
USB-SSD
In Commercial Distribution

  • 00810591020109 ()
USB-SSD

  • Cardiac mapping system
Spine Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81043
In Commercial Distribution

  • 07613327546347 ()
81-81043

  • Surgical planning/navigation-enhancement system
Spine Guidance Enable
Stryker Leibinger GmbH & Co. KG
6002-710-300
In Commercial Distribution

  • 07613327545913 ()
6002-710-300

  • Surgical planning/navigation-enhancement system
Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.88
In Commercial Distribution

  • B109VISAR2880 ()


  • Surgical planning/navigation-enhancement system
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.73
In Commercial Distribution

  • B109VISAR2730 ()


  • Surgical planning/navigation-enhancement system
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.1.5
In Commercial Distribution

  • B109VISAR2150 ()


  • Surgical planning/navigation-enhancement system
CRANIALMAP PLANNING
Stryker Leibinger GmbH & Co. KG
6000-661-000
In Commercial Distribution

  • 07613327327212 ()
6000-661-000

  • Surgical planning/navigation-enhancement system
CRANIALMAP SERVICE UPGRADE
Stryker Leibinger GmbH & Co. KG
6000-660-150
In Commercial Distribution

  • 07613327327205 ()
6000-660-150

  • Surgical planning/navigation-enhancement system
CRANIALMAP
Stryker Leibinger GmbH & Co. KG
6000-660-000
In Commercial Distribution

  • 07613327327199 ()
6000-660-000

  • Surgical planning/navigation-enhancement system
CRANIALMAP SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81036
In Commercial Distribution

  • 07613327327182 ()
81-81036

  • Surgical planning/navigation-enhancement system
CRANIALMAP ENABLE
Stryker Leibinger GmbH & Co. KG
6000-660-300
In Commercial Distribution

  • 07613327327175 ()
6000-660-300

  • Surgical planning/navigation-enhancement system
CRANIALMAP PLANNING SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81037
In Commercial Distribution

  • 07613327327151 ()
81-81037

  • Surgical planning/navigation-enhancement system
CRANIALMAP UPGRADE
Stryker Leibinger GmbH & Co. KG
6000-660-100
In Commercial Distribution

  • 07613327327137 ()
6000-660-100

  • Surgical planning/navigation-enhancement system
ADAPT 2.1 for Gamma3 SW
Stryker GmbH
0101-0002
In Commercial Distribution

  • 07613327512175 ()
0101-0002

  • Medical image management system
Twist Drill Sleeve
Stryker Leibinger GmbH & Co. KG
6000-804-030
In Commercial Distribution

  • 07613327468274 ()
6000-804-032

  • Surgical planning/navigation-enhancement system
Arm Connector Component
Stryker Leibinger GmbH & Co. KG
6000-806-000
In Commercial Distribution

  • 07613327467253 ()
6000-806-000

  • Surgical planning/navigation-enhancement system
Elite Drill Sleeve
Stryker Leibinger GmbH & Co. KG
6000-804-060
In Commercial Distribution

  • 07613327467246 ()
6000-804-060

  • Surgical planning/navigation-enhancement system
Needle Sleeve
STRYKER CORPORATION
6000-805-021
In Commercial Distribution

  • 07613327467239 ()
6000-805-021

  • Surgical planning/navigation-enhancement system
Precision Targeting Arm
Stryker Leibinger GmbH & Co. KG
6000-801-000
In Commercial Distribution

  • 07613327467222 ()
6000-801-000

  • Surgical planning/navigation-enhancement system
Tracker Sleeve
Stryker Leibinger GmbH & Co. KG
6000-803-000
In Commercial Distribution

  • 07613327467215 ()
6000-803-000

  • Surgical planning/navigation-enhancement system
Precision Targeting Guide
Stryker Leibinger GmbH & Co. KG
6000-802-000
In Commercial Distribution

  • 07613327467208 ()
6000-802-000

  • Surgical planning/navigation-enhancement system
No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system
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