510(k) Report

FDA applicant

Mennen Medical, Inc.

Clarence, NY55 decisions1985–20150 recalls

FDA records 55 decisions for Mennen Medical, Inc. (Clarence, NY) from 1985 to 2015: 55 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DQK (Computer, Diagnostic, Programmable). Its devices cite 33 predicates, 25 of them its own earlier devices. No recall is linked to its devices.

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

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

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

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

FDA decisions per year

1in 2015

2007: 42008: 22009: 12010: 12013: 22015: 1
2007high 4 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Mennen”

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