FDA applicant
Stryker Instruments, Instruments Div.
FDA records 6 decisions for Stryker Instruments, Instruments Div. (Kalamazoo, MI) from 2007 to 2013: 6 510(k) clearances. Most are in product codes NDN (Cement, Bone, Vertebroplasty) and FYA (Gown, Surgical). Its devices cite 14 predicates, 1 of them its own earlier devices. 28 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stryker Instruments, Instruments Div.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
11in 2018
Class I Class II/III not classified
Planning a device like Stryker Instruments, Instruments Div.’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 “Stryker”
FDA records each applicant name separately; these may or may not be the same firm.