FDA applicant
Edlaw Pharmaceuticals, Inc.
FDA records 3 decisions for Edlaw Pharmaceuticals, Inc. (Mchenry, IL) from 1981 to 1984: 3 510(k) clearances. Most are in product codes KPO (Dialysate Concentrate For Hemodialysis (Liquid…) and KOC (Accessories, Blood Circuit, Hemodialysis). 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 Edlaw Pharmaceuticals, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Edlaw Pharmaceuticals, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Edlaw Pharmaceuticals, 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