510(k) Report

FDA applicant

Medical Monofilament Manufacturing

Plymouth, MA1 decision2015–20150 recalls

FDA records 1 decision for Medical Monofilament Manufacturing (Plymouth, MA) in 2015: 1 510(k) clearance. All are in product code GXB (Esthesiometer). No recall is 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 Medical Monofilament Manufacturing’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Medical Monofilament Manufacturing by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXBEsthesiometer1decision

What has FDA decided for it lately?

  • K143068Medical Monofilament Sensory Screening TooolMedical Monofilament Manufacturing · 2015

The one decision as Medical Monofilament Manufacturing →