FDA applicant

Neuro Therm, Inc.

Ashland, MA3 decisions2006–20134 recalls

FDA records 3 decisions for Neuro Therm, Inc. (Ashland, MA) from 2006 to 2013: 3 510(k) clearances. Most are in product codes GXD (Generator, Lesion, Radiofrequency) and NDN (Cement, Bone, Vertebroplasty). Its devices cite 6 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Neuro Therm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Neuro Therm, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neuro Therm, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Neuro”

FDA records each applicant name separately; these may or may not be the same firm.

Neuro Navigational Corp. 23 Neuro Supplies, Inc. 5 Neuro Technology 5 Neuro Kinetics, Inc. 4 Neuro Resource Group, Inc. 4 Neuro Scan Labs 3 Neuro Vasx, Inc. 2 Neuro-Biometrix, Inc. 2 Neuro-Diagnostic Assoc. 2 Neuro Event Labs OY 1 Neuro-Fitness, LLC 1 Neuro Diagnostic Devices 1

Neuro Therm, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Neuro”