FDA applicant
Datamed, Inc.
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
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.
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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