Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Intersect ENT, Inc. with 1 510(k) clearance, 1 drug recall, 1 device recall and 1 drug application. The most recent is a drug recall dated Jan 4, 2023: SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, inter….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 4, 2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDClass III · Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification | Drug recalls |
| Oct 21, 2022 | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044Class II · Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect | Device recalls |
| Feb 4, 2022 | VenSure LightGuideK212774 · LRC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
