FDA applicant
Berwick Medical Products, Inc.
FDA records 5 decisions for Berwick Medical Products, Inc. (Mchenry, IL) from 1983 to 1985: 5 510(k) clearances. Most are in product codes KEA (Resins, Ion-Exchange) and DJY (Ion-Exchange Chromatography). 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 Berwick Medical Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Berwick Medical Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Berwick Medical Products, Inc.’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