FDA applicant
Pharmaseal Div., Baxter Healthcare Corp.
FDA records 24 decisions for Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, IL) from 1976 to 1979: 24 510(k) clearances. Most are in product codes KNX (Collector, Urine, (And Accessories) For…) and FMF (Syringe, Piston). 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 Pharmaseal Div., Baxter Healthcare Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pharmaseal Div., Baxter Healthcare Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pharmaseal Div., Baxter Healthcare Corp.’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) ReportOther applicant names beginning “Pharmaseal”
FDA records each applicant name separately; these may or may not be the same firm.