FDA applicant
E-Z-Em, Inc.
FDA records 56 decisions for E-Z-Em, Inc. (Westbury, NY) from 1977 to 2007: 56 510(k) clearances. Most are in product codes FCX (Insufflator, Automatic Carbon-Dioxide For…) and HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). Its devices cite 8 predicates, 7 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided E-Z-Em, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2007
2026 so far, outlined.
Recalls per year
3in 2014
Class I Class II/III not classified
Planning a device like E-Z-Em, 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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