510(k) Report

FDA applicant

Stryker Ireland Ltd., Instruments Division

Carrigtwohill, Co.Cork, IE2 decisions2008–20081 recall

FDA records 2 decisions for Stryker Ireland Ltd., Instruments Division (Carrigtwohill, Co.Cork, IE) in 2008: 2 510(k) clearances. Most are in product codes ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…) and HBF (Drills, Burrs, Trephines & Accessories…). Its devices cite 5 predicates, 0 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, ear, nose and throat panel, where it files most

How often FDA has decided Stryker Ireland Ltd., Instruments Division’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2008: 2
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2008high 1 (2020) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Stryker Ireland Ltd., Instruments Division by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stryker Ireland Ltd., Instruments…’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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Which product codes does it file in?

  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece1decision
  • HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082010Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 20081cites it

What has FDA decided for it lately?

  • K082010Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 20081 recall
  • K073633Stryker Essx Microdebrider SystemStryker Ireland Ltd., Instruments Division · 2008

All 2 as Stryker Ireland Ltd., Instruments Division →

What has been recalled?

1 recall linked to its devices; the latest:

  • K082010Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use…Oct 16, 2020Class II

Other applicant names beginning “Stryker”

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

Stryker Corp. 354Stryker Endoscopy 103Stryker Instruments 77Stryker Spine 76Stryker Leibinger GmbH & Co KG 36Stryker Neurovascular 36Stryker Sustainability Solutions 34Stryker Trauma AG 32Stryker Orthopaedics 24Stryker Medical 14Stryker Instruments, Instruments Div. 6Stryker Corporate 6