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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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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
Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00500-1c
In Commercial Distribution

  • 05713867000193 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00500-1a
In Commercial Distribution

  • 05713867000186 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1c
In Commercial Distribution

  • 05713867000179 ()


  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1b
In Commercial Distribution

  • 05713867000162 ()


  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
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