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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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The NEUROMARK System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The NEUROMARK Device is operated via handle, slider and activation button. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console; it includes features to allow compatibility and authentication once connected, via a flexible interface cable, to the Console.
NEURENT MEDICAL LIMITED
FS-004-01
In Commercial Distribution

  • 05391537940095 ()
NMK-2001-05

  • Electrosurgical system
The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator via a flexible cable. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities. The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile cart for ease of use. The mobile cart includes a handle and basket. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.
NEURENT MEDICAL LIMITED
010-00043-000
Not in Commercial Distribution

  • 05391537940026 ()


  • Electrosurgical system
The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is a hand-held single-use bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar radiofrequency energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled radiofrequency energy level delivery. The NEUROMARK™ Device is operated via handle, slider and activation switch. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Generator. The NEUROMARK Device includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK Radiofrequency Generator.
NEURENT MEDICAL LIMITED
FS-002
Not in Commercial Distribution

  • 05391537940002 ()
  • 05391537940019 ()
  • 05391537940033 ()


  • Electrosurgical system
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-H/P
In Commercial Distribution

  • 08809709380466 ()


  • Electrosurgical system
XTHERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-Body
In Commercial Distribution

  • 08809709380459 ()


  • Electrosurgical system
10THERMA Handpiece
TENTECH Inc.
TMHP02
In Commercial Distribution

  • 08809709380350 ()


  • Electrosurgical system
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
TMSY02
In Commercial Distribution

  • 08809709380343 ()


  • Electrosurgical system
No Description
Joimax GmbH
JVAPA15035
In Commercial Distribution

  • 04250337120230 ()
  • 04250337120223 ()


  • Electrosurgical system
Surgi-Max™ Disposable Trigger-Flex™
Joimax GmbH
JSMITF32
In Commercial Distribution

  • 04250337120032 ()

  • probe, inside emitting L 320 mm / OD 2.5 mm
JSMITF32

  • Electrosurgical system
Surgi-Max™ Disposable Trigger-Flex™
Joimax GmbH
JSMDTF40
In Commercial Distribution

  • 04250337120018 ()

  • Probe, distal emitting L 400 mm / OD 2.5 mm
JSMDTF40

  • Electrosurgical system
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