5 results
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27ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural tissue.
FDA Recall
Terminated
·Neurotherm, Inc.·Product code GXI·July 28, 2008
Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
FDA Recall
Terminated
·Neurotherm, Inc.·Product code GXI·February 26, 2013
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Recall
Terminated
·Neurotherm, Inc.·Product code GXD·October 9, 2013
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Enforcement
Class II
·Terminated·Neurotherm, Inc.·April 20, 2016
Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
FDA Enforcement
Class II
·Terminated·Neurotherm, Inc.·March 30, 2016