FDA applicant
Warne Surgical Products, Ltd.
FDA records 15 decisions for Warne Surgical Products, Ltd. (Mchenry, IL) from 1984 to 1985: 15 510(k) clearances. Most are in product codes FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…) and KNX (Collector, Urine, (And Accessories) For…). 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 Warne Surgical Products, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Warne Surgical Products, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Warne Surgical Products, 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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