FDA applicant

Integra Biotechnical, LLC

Oceanside, CA1 decision1998–19980 recalls

FDA records 1 decision for Integra Biotechnical, LLC (Oceanside, CA) in 1998: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Integra Biotechnical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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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 Life Sciences 3 Integra Medical 2 Integra Lifescience Corportation 2 Integra Lifesciences Corporation (Owner of Tei… 1 Integra Microfrance 1 Integra Burlington Ma, Inc. 1

Integra Biotechnical, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Integra”