FDA applicant

Integra Luxtec, Inc.

West Boylston, MA1 decision2008–20084 recalls

FDA records 1 decision for Integra Luxtec, Inc. (West Boylston, MA) in 2008: 1 510(k) clearance. All are in product code FCW (Light Source, Fiberoptic, Routine). 4 recalls are linked to its devices.

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 Integra Luxtec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

4in 2011

2008high 4 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Integra Luxtec, Inc. by year, 2008–2026Sources: 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 Biotechnical, LLC 1

Integra Luxtec, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Integra”