FDA applicant
Integra LifeSciences Corporation
FDA records 101 decisions for Integra LifeSciences Corporation (Planisboro, NJ) from 1981 to 2025: 94 510(k) clearances and 7 original PMA approvals. Most are in product codes JXG (Shunt, Central Nervous System And Components) and LFL (Instrument, Ultrasonic Surgical). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 164 predicates, 47 of them its own earlier devices. 130 recalls are linked to its devices, 6 Class I.
FDA’s records also spell it “Integra Lifesciences Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Integra LifeSciences Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Integra LifeSciences Corporation’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) ReportOther applicant names beginning “Integra”
FDA records each applicant name separately; these may or may not be the same firm.