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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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PWDII50DF AIM CL K3 11
MAQUET SAS
ARDPWT209152A
Not in Commercial Distribution

  • 03700712416027 ()


  • Operating room light
PWDII50DF AIM XHS010 K4 1011
MAQUET SAS
ARDPWT239282A
Not in Commercial Distribution

  • 03700712416010 ()


  • Operating room light
A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
KOELIS
KURO3000-2
Not in Commercial Distribution

  • 03665134000547 ()
  • 03665134000035 ()
  • 03665134000554 ()


  • General-purpose ultrasound imaging system
Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
Not in Commercial Distribution

  • 17958909771661 ()
  • 07958909771664 ()


  • Infrared patient thermometer, skin
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 00935712300004 ()
MXU-RV01

  • Mobile basic diagnostic x-ray system, digital
The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI11700 ()
1170

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation.
g.tec medical engineering GmbH
1
In Commercial Distribution

  • EBCI11500 ()
1150

  • Cortical electrode
The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2070
In Commercial Distribution

  • EAMITRI20700 ()
TRI2070

  • Noninvasive vascular ultrasound system
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2010
Not in Commercial Distribution

  • EAMITRI20100 ()

  • Height: 7 Centimeter
  • Outer Diameter: 23 Centimeter
TRI2010

  • Noninvasive vascular ultrasound system
Codman® CereLink® ICP Monitor
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
826820
In Commercial Distribution

  • 10381780533788 ()
826820

  • Intracranial pressure monitor
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