FDA applicant
North American Instrument Corp.
FDA records 28 decisions for North American Instrument Corp. (Glens Falls, NY) from 1983 to 1996: 28 510(k) clearances. Most are in product codes DTL (Adaptor, Stopcock, Manifold, Fitting…) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 1 predicate, 1 of them its own earlier devices. 9 recalls are linked to its devices, 4 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided North American Instrument Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for North American Instrument Corp. since 2007.
Recalls per year
3in 2026
Class I Class II/III not classified
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