FDA applicant

Stryker Corporate

Freiburg, Baden-Wuerttemberg, DE6 decisions2013–20161 recall

FDA records 6 decisions for Stryker Corporate (Freiburg, Baden-Wuerttemberg, DE) from 2013 to 2016: 6 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HAW (Neurological Stereotaxic Instrument). Its devices cite 13 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2016

2013high 2 (2013) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2017

2013high 1 (2017) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Stryker Corporate by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stryker Corporate’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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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 Medical 14 Stryker Instruments, Instruments Div. 6 Stryker Corporation (Tornier, Inc.) 5

Stryker Corporate

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?

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Other applicant names beginning “Stryker”