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Neuro Therm, Inc.

Last updated May 23, 2026

Information

Country: US
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DUNS Number: —

Catalogue (105)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	AC-B-DUK	FDA UDI	Class II	Active
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	NRFE-15	FDA UDI	Class II	Active
NeuroTherm™	RFE-5-S	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	RFE-10-S	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	RFE-15	FDA UDI	Class II	Active
NeuroTherm™	AC-SN-NT	FDA UDI	Class II	Active
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	AC-B-NT	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	RFE-10	FDA UDI	Class II	Active
NeuroTherm™	RFDEUK-10	FDA UDI	Class II	Active
NeuroTherm™	RF-DGP-L	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	RFDE-10	FDA UDI	Class II	Unknown
NeuroTherm™	NRFE-10	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	RFDEUK-20	FDA UDI	Class II	Unknown
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	RFE-15-S	FDA UDI	Class II	Active
NeuroTherm™	AC-IDET-8	FDA UDI	Class II	Active
NeuroTherm	RF-DGP-C	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	RFDE-20	FDA UDI	Class II	Active
NeuroTherm™	SL	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	CLASSIC	FDA UDI	Class II	Active
NeuroTherm™	SMK	FDA UDI	Class II	Active
NeuroTherm™	DACUK-NT	FDA UDI	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 9, 2013	Z-1361-2016	—	terminated	NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.
Feb 26, 2013	Z-1247-2016	—	terminated	Straight needle labeled as a curved needle
Jul 28, 2008	Z-0838-2009	—	terminated	Distal tip may detach from the probe