FDA applicant

Stryker Communications Corp.

Flower Mound, TX4 decisions2004–201315 recalls

FDA records 4 decisions for Stryker Communications Corp. (Flower Mound, TX) from 2004 to 2013: 4 510(k) clearances. Most are in product codes FSY (Light, Surgical, Ceiling Mounted) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 10 predicates, 2 of them its own earlier devices. 15 recalls are linked to its devices.

FDA’s records also spell it “Stryker Communications”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2013

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 7 (2010) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Stryker Communications 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) 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 Medical 14 Stryker Instruments, Instruments Div. 6 Stryker Corporate 6

Stryker Communications Corp.

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”