FDA applicant
Stryker Corp.
FDA records 354 decisions for Stryker Corp. (Kalamazoo, MI) from 1976 to 2026: 352 510(k) clearances and 2 original PMA approvals. Most are in product codes HRS (Plate, Fixation, Bone) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 613 predicates, 199 of them its own earlier devices. 219 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Stryker”, “Stryker Corporation”, “Stryker GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stryker Corp.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like Stryker 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 “Stryker”
FDA records each applicant name separately; these may or may not be the same firm.