FDA applicant

Stryker Medical

Kalamazoo, MI14 decisions1991–20234 recalls

FDA records 14 decisions for Stryker Medical (Kalamazoo, MI) from 1991 to 2023: 14 510(k) clearances. Most are in product codes FPO (Stretcher, Wheeled) and DWJ (System, Thermal Regulating). Its devices cite 5 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Stryker Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2018

2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stryker Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stryker Medical’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) Report

Other applicant names beginning “Stryker”

FDA records each applicant name separately; these may or may not be the same firm.

Stryker Corp. 354 Stryker Endoscopy 103 Stryker Instruments 77 Stryker Spine 76 Stryker Leibinger GmbH & Co KG 36 Stryker Neurovascular 36 Stryker Sustainability Solutions 34 Stryker Trauma AG 32 Stryker Orthopaedics 24 Stryker Instruments, Instruments Div. 6 Stryker Corporate 6 Stryker Corporation (Tornier, Inc.) 5

Stryker Medical

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Stryker”