FDA applicant

Integra Burlington Ma, Inc.

Burlington, MA1 decision2012–20120 recalls

FDA records 1 decision for Integra Burlington Ma, Inc. (Burlington, MA) in 2012: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). Its devices cite 1 predicate, 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

How often FDA has decided Integra Burlington Ma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Integra Burlington Ma, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Integra Burlington Ma, Inc.’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 “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 Burlington Ma, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Integra”