FDA applicant

Medtech S.A.S

Mauguio, FR4 decisions1999–202312 recalls

FDA records 4 decisions for Medtech S.A.S (Mauguio, FR) from 1999 to 2023: 4 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 6 predicates, 1 of them its own earlier devices. 12 recalls are linked to its devices.

FDA’s records also spell it “Medtech , Ltd.”.

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 Medtech S.A.S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 4 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medtech S.A.S’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 “Medtech”

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

Medtech Products, Inc. 14 Medtech S.A 8 Medtech Intl., Inc. 6 Medtech Industries, Inc. 4 The Medtech Group, Inc. 2 Medtech Instruments 2 Medtech Systems, Inc. 1

Medtech S.A.S

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 “Medtech”