FDA applicant
Diametrics Medical, Inc.
FDA records 11 decisions for Diametrics Medical, Inc. (Roseville, MN) from 1995 to 2003: 11 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and CCC (Analyzer, Gas, Carbon-Dioxide, Partial…). Its devices cite 7 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Diametrics Medical, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Diametrics Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Diametrics Medical, Inc. since 2007.
Recalls per year
3in 2015
Class I Class II/III not classified
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