FDA applicant

Mapa Professional

Saltillo Coah, MX1 decision2000–20000 recalls

FDA records 1 decision for Mapa Professional (Saltillo Coah, MX) in 2000: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). 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, general hospital panel, where it files most

How often FDA has decided Mapa Professional’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mapa Professional since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mapa Professional’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 “Mapa”

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

Mapa GmbH 3

Mapa Professional

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Mapa”