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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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WS accessory pack
Given Imaging, Inc.
FGS-0410
In Commercial Distribution

  • 07290101362128 ()


  • Video capsule endoscopy system application software
PillCam Software v9.0 WW WS
Given Imaging, Inc.
FGS-0626
In Commercial Distribution

  • 07290101369530 ()


  • Video capsule endoscopy system application software
recorder DR3 SW upgrade
Given Imaging, Inc.
FGS-0619
In Commercial Distribution

  • 07290101366904 ()


  • Video capsule endoscopy system application software
PillCam Software Upgrade v9 , USA
Given Imaging, Inc.
FGS-0613
In Commercial Distribution

  • 07290101366768 ()


  • Video capsule endoscopy system application software
PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software
WS, Dell T5810 V8.3 US
Given Imaging, Inc.
FGS-0600
In Commercial Distribution

  • 07290101366478 ()


  • Video capsule endoscopy system application software
WS, Dell T5810 V8.0 US
Given Imaging, Inc.
FGS-0599
In Commercial Distribution

  • 07290101366461 ()


  • Video capsule endoscopy system application software
WS, Dell T3600 V8.5 US
Given Imaging, Inc.
FGS-0577
In Commercial Distribution

  • 07290101366058 ()


  • Video capsule endoscopy system application software
SW kit, v8.0 US WS
Given Imaging, Inc.
FGS-0542
In Commercial Distribution

  • 07290101365280 ()


  • Video capsule endoscopy system application software
SW kit, v8.0 US
Given Imaging, Inc.
FGS-0540
In Commercial Distribution

  • 07290101365266 ()


  • Video capsule endoscopy system application software
SW kit, v8.0 SCA WS
Given Imaging, Inc.
FGS-0480-01
In Commercial Distribution

  • 07290101365013 ()


  • Video capsule endoscopy system application software
RAPID® SW kit, v8.0 SCA
Given Imaging, Inc.
FGS-0478-01
In Commercial Distribution

  • 07290101364993 ()


  • Video capsule endoscopy system application software
SW upgrade, v8.3 US
Given Imaging, Inc.
FGS-0524
In Commercial Distribution

  • 07290101364863 ()


  • Video capsule endoscopy system application software
WS, Dell T3400, US
Given Imaging, Inc.
FGS-0485
In Commercial Distribution

  • 07290101364184 ()


  • Video capsule endoscopy system application software
PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software
PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software
PillCam™ Recorder DR3 SW upgrade
Given Imaging, Inc.
FGS-0664
In Commercial Distribution

  • 07290110360719 ()


  • Video capsule endoscopy system application software
PillCam™ WS v9 Dell T5810, USA
Given Imaging, Inc.
FGS-0640
In Commercial Distribution

  • 07290110360221 ()


  • Video capsule endoscopy system application software
PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software
PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution

  • 07290110360191 ()


  • Video capsule endoscopy system application software
2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0502
Not in Commercial Distribution

  • 00885074322889 ()


  • Electromyograph
G3 KEYPOINT WORKSTATION US
Alpine Biomed ApS
9031A0064AA
Not in Commercial Distribution

  • 00885074291635 ()


  • Electromyograph
KEYPOINT WORKST IT
Alpine Biomed ApS
9031A006406
Not in Commercial Distribution

  • 00885074291611 ()


  • Electromyograph
KEYPOINT WORKST NL
Alpine Biomed ApS
9031A006405
Not in Commercial Distribution

  • 00885074291598 ()


  • Electromyograph
KEYPOINT WORKST SP
Alpine Biomed ApS
9031A006404
Not in Commercial Distribution

  • 00885074291574 ()


  • Electromyograph
G3 KEYPOINT WORKSTATION GE
Alpine Biomed ApS
9031A006403
Not in Commercial Distribution

  • 00885074291567 ()


  • Electromyograph
KEYPOINT WORKST FR
Alpine Biomed ApS
9031A006402
Not in Commercial Distribution

  • 00885074291529 ()


  • Electromyograph
KEYPOINT WORKST UK
Alpine Biomed ApS
9031A006401
Not in Commercial Distribution

  • 00885074291499 ()


  • Electromyograph
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
ACUMEN AFM CABLE
Edwards Lifesciences LLC
AAFMC
In Commercial Distribution

  • 00690103206951 ()
AAFMC

  • General-purpose multi-parameter bedside monitor
ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
Edwards Lifesciences LLC
AIQSFM6C502
In Commercial Distribution

  • 50690103205836 ()
  • 00690103205831 ()
AIQSFM6C502

  • Intravenous line sensor, gravity infusion
Acumen IQ Fluid Meter
Edwards Lifesciences LLC
AIQFM10
In Commercial Distribution

  • 50690103205829 ()
  • 00690103205824 ()
AIQFM10

  • Intravenous line sensor, gravity infusion
Acumen IQ Fluid Meter
Edwards Lifesciences LLC
AIQFM
In Commercial Distribution

  • 00690103205817 ()
AIQFM

  • Intravenous line sensor, gravity infusion
ACUMEN IQ SENSOR 84'' / 213CM WITH FLUID METER 5-PACK
Edwards Lifesciences LLC
AIQSFM85
In Commercial Distribution

  • 50690103205805 ()
  • 00690103205800 ()
AIQSFM85

  • Electronic gravity infusion controller
ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK
Edwards Lifesciences LLC
AIQSFM6AZ5
In Commercial Distribution

  • 50690103205782 ()
  • 00690103205787 ()
AIQSFM6AZ5

  • Intravenous line sensor, gravity infusion
ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK
Edwards Lifesciences LLC
AIQSFM65
In Commercial Distribution

  • 50690103205768 ()
  • 00690103205763 ()
AIQSFM65

  • Intravenous line sensor, gravity infusion
CAM HD - MDR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
HD
In Commercial Distribution

  • 00195278421456 ()
900995-103

  • Electrocardiograph, professional, multichannel
MAC 5 A5
Ge Medical Systems Information Technologies, Inc.
5 A5
In Commercial Distribution

  • 00195278276124 ()
8855002-001

  • Electrocardiograph, professional, multichannel
MAC 5 Lite
Ge Medical Systems Information Technologies, Inc.
5 LITE
In Commercial Distribution

  • 00195278276087 ()
8855003-001

  • Electrocardiograph, professional, multichannel
MAC 5 A4
Ge Medical Systems Information Technologies, Inc.
5 A4
In Commercial Distribution

  • 00195278276070 ()
8855001-001

  • Electrocardiograph, professional, multichannel
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