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., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 13, 2026, FDA's public records list Acclarent with 44 510(k) clearances and 13 device recalls. The most recent is a 510(k) clearance dated Feb 19, 2026: Acclarent AERA Eustachian Tube Balloon Dilation System.
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.
| Date | Record | Source |
|---|---|---|
| Feb 19, 2026 | Acclarent AERA Eustachian Tube Balloon Dilation SystemK253612 · PNZ | 510(k) clearances |
| Dec 13, 2023 | ACCLARENT AERA Eustachian Tube Dilation SystemK230742 · PNZ | 510(k) clearances |
| Sep 21, 2023 | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005Class II · When using affected curette and software, there is a discrepancy between the actual curette tip location and the locatio | Device recalls |
| Jul 21, 2023 | TruDi® Navigation System V3 (FG-2000-00)K231862 · PGW | 510(k) clearances |
| Jul 20, 2022 | TruDi Shaver BladeK221037 · PGW | 510(k) clearances |
| Nov 12, 2021 | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090ZClass II · Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verifi | Device recalls |
| Aug 27, 2020 | Next Generation Balloon Dilation SystemK201115 · LRC | 510(k) clearances |
| Aug 12, 2020 | TruDi CuretteK201174 · PGW | 510(k) clearances |
| Mar 23, 2020 | TruDi ProbeK193453 · PGW | 510(k) clearances |
| May 3, 2019 | RELIEVA ULTIRRA Sinus Balloon CatheterK190525 · LRC | 510(k) clearances |
| Mar 6, 2019 | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884Class II · The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect t | Device recalls |
| Mar 6, 2019 | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891Class II · The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect t | Device recalls |
| Mar 6, 2019 | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877Class II · The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect t | Device recalls |
| Apr 28, 2015 | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access tClass III · Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. | Device recalls |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.Class II · Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings | Device recalls |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.Class II · Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings | Device recalls |
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
