FDA applicant
American Heyer Schulte
FDA records 13 decisions for American Heyer Schulte (Mchenry, IL) from 1980 to 1984: 13 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and GCY (Apparatus, Suction, Single Patient Use…). 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided American Heyer Schulte’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Heyer Schulte since 2007.
Recalls per year
5in 2011
Class I Class II/III not classified
Planning a device like American Heyer Schulte’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report