510(k) Report

FDA applicant

Datamed, Inc.

Walker, MI3 decisions1981–19910 recalls

FDA records 3 decisions for Datamed, Inc. (Walker, MI) from 1981 to 1991: 3 510(k) clearances. Most are in product codes BTX (Board, Arm (With Cover), Sterile) and BSE (Analyzer, Gas, Helium, Gaseous-Phase). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Datamed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Datamed, 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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