FDA applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
FDA records 66 decisions for Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, MA) from 1989 to 1997: 66 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and CAZ (Anesthesia Conduction Kit). Its devices cite 10 predicates, 2 of them its own earlier devices. 19 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kendall Healthcare Products Co. Div.Of Tyco Health’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kendall Healthcare Products Co. Div.Of Tyco Health since 2007.
Recalls per year
11in 2020
Class I Class II/III not classified
Planning a device like Kendall Healthcare Products Co. Div.Of…’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 “Kendall”
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