FDA applicant

Infarkem Corp.

Hartsdale, NY3 decisions1985–19850 recalls

FDA records 3 decisions for Infarkem Corp. (Hartsdale, NY) in 1985: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FJK (Set, Tubing, Blood, With And Without…). 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 Infarkem Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infarkem Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Infarkem Corp.

Which product codes does it file in?

What has FDA decided for it lately?