FDA applicant
Pollak (Intl.), Ltd.
FDA records 31 decisions for Pollak (Intl.), Ltd. (Mchenry, IL) from 1980 to 2000: 31 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and FMC (Patient Examination Glove). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pollak (Intl.), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pollak (Intl.), Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pollak (Intl.), Ltd.’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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