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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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ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 8ch WLAN
Not in Commercial Distribution

  • 06430035220243 ()


  • Electromyograph
ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 4ch WLAN
Not in Commercial Distribution

  • 06430035220236 ()


  • Electromyograph
ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 16ch
Not in Commercial Distribution

  • 06430035220212 ()


  • Electromyograph
ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 8ch
Not in Commercial Distribution

  • 06430035220205 ()


  • Electromyograph
ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Bittium Biosignals Oy
ME6000 4ch
Not in Commercial Distribution

  • 06430035220199 ()


  • Electromyograph
Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.
Bittium Biosignals Oy
Cover
Not in Commercial Distribution

  • 06430035220021 ()


  • Electromyograph
FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.
Bittium Biosignals Oy
HTCS-2
Not in Commercial Distribution

  • 06430035220014 ()


  • Electromyograph
STROBE CASE F/FLEX SCOPE & HIGH LT
JEDMED INSTRUMENT COMPANY
49-4991
In Commercial Distribution

  • M6334949910 ()
49-4991

  • Laryngostroboscope system
No Description
Medical Measurement Systems B.V.
HEM FS
In Commercial Distribution

  • 08717775955870 ()


  • Electromyograph
No Description
Medical Measurement Systems B.V.
HEM
In Commercial Distribution

  • 08717775955702 ()


  • Electromyograph
KARL STORZ PULSAR II Stroboscope
Karl Storz GmbH & Co. KG
40160120
In Commercial Distribution

  • 04048551242513 ()


  • Laryngostroboscope system
K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo Black V3
In Commercial Distribution

  • 03770011995875 ()


  • Electromyograph
K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo V3
In Commercial Distribution

  • 03770011995707 ()


  • Electromyograph
The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsule system, designed to be worn by the patient. The transceiver continuously monitors and transmits information from the Heidelberg pH capsule. The transceiver’s internal firmware also monitors the pH capsule’s strength in real time, calibration accuracy and pH levels. The pH capsule’s information received by the transceiver is sent by telemetry to the Heidelberg interface module. The Interface module forwards the Medallion Transceiver’s information to the computer for display.
Heidelberg Medical Inc
Heidelberg Medallion Transceiver
In Commercial Distribution

  • B989HMT00180 ()
HMT0018

  • Gastrointestinal telemetric monitoring system transceiver
The interface module is a stationary electronic component of the Heidelberg pH capsule telemetric monitoring system designed to continuously monitor incoming date from the Heidelberg transceiver. The interface transmits the incoming pH data and events from the transceiver and assigns a specific channel to the data and routes it to the computer for display on one to eight graphs.
Heidelberg Medical Inc
Heidelberg Interface Module
In Commercial Distribution

  • B989HMI1180 ()
HMI118

  • Gastrointestinal telemetric monitoring system receiver
SENSOR BATTERY DEVICE ASSEMBLY
GE Healthcare Finland Oy
SBT01
In Commercial Distribution

  • 00195278366085 ()
  • 00195278120014 ()
2096442-001

  • Multiple vital physiological parameter monitoring system transceiver
PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software
PillCam (TM) Desktop Software v9.7
Given Imaging, Inc.
FGS-0802
In Commercial Distribution

  • 10884521845916 ()


  • Video capsule endoscopy system application software
PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software
Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator
ANX ROBOTICA CORP
Controller/ NaviEC-2000
In Commercial Distribution

  • 00850015518294 ()
MC-US-1002

  • Video capsule endoscopy system capsule magnetic manipulation unit
Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
ANX ROBOTICA CORP
Controller/NaviEC-1000
In Commercial Distribution

  • 00850015518201 ()
MC-US-1001

  • Video capsule endoscopy system capsule magnetic manipulation unit
Endeavor CR Desktop PC
NATUS NEUROLOGY INCORPORATED
842-128400
In Commercial Distribution

  • 00382830034579 ()


  • Electromyograph
Viking Control Panel - French
NATUS NEUROLOGY INCORPORATED
842-129800
In Commercial Distribution

  • 00382830034494 ()


  • Electromyograph
2015 Visual Stimulator Only
NATUS NEUROLOGY INCORPORATED
842-647900
In Commercial Distribution

  • 00382830034395 ()


  • Electromyograph
2015 Visual Stimulator with LCD Monitor
NATUS NEUROLOGY INCORPORATED
842-648300
In Commercial Distribution

  • 00382830034357 ()


  • Electromyograph
Viking EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689400
In Commercial Distribution

  • 00382830033893 ()


  • Electromyograph
EDX Desktop PC
NATUS NEUROLOGY INCORPORATED
842-689700
In Commercial Distribution

  • 00382830033848 ()


  • Electromyograph
EDX Laptop PC
NATUS NEUROLOGY INCORPORATED
842-689900
In Commercial Distribution

  • 00382830033824 ()


  • Electromyograph
EDX 3 channel Amplifier
NATUS NEUROLOGY INCORPORATED
842-691800
In Commercial Distribution

  • 00382830033749 ()


  • Electromyograph
EDX 4 channel Amplifier
NATUS NEUROLOGY INCORPORATED
842-691900
In Commercial Distribution

  • 00382830033725 ()


  • Electromyograph
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