FDA applicant

Integra Life Sciences

Irvine, CA3 decisions2011–20120 recalls

FDA records 3 decisions for Integra Life Sciences (Irvine, CA) from 2011 to 2012: 3 510(k) clearances. Most are in product codes MBP (Filler, Bone Void, Osteoinduction (W/O Human…) and GXQ (Dura Substitute). Its devices cite 5 predicates, 0 of them its own earlier devices. No 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, orthopedic panel, where it files most

How often FDA has decided Integra Life Sciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Integra Life Sciences by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Integra Life Sciences’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 “Integra”

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

Integra LifeSciences Corporation 101 Integra Neurocare, LLC 12 Integra Radionics, Inc. 10 Integra Neurosciences 9 Integra Lifesciences Production Corporation 9 Integra Neurosciences Implants S.A. 6 Integra Medical 2 Integra Lifescience Corportation 2 Integra Lifesciences Corporation (Owner of Tei… 1 Integra Microfrance 1 Integra Biotechnical, LLC 1 Integra Burlington Ma, Inc. 1

Integra Life Sciences

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?

Other applicant names beginning “Integra”