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Acclarent, Inc.

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette recall (Z-0127-2024)Acclarent, Inc.2023-10-20
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Cath recall (Z-1740-2015)Acclarent, Inc.2015-06-09
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of ai recall (Z-1860-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of ai recall (Z-1861-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of a recall (Z-1862-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1863-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1864-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1865-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1866-2013)Acclarent, Inc.2013-08-01
Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G recall (Z-1095-2012)Acclarent, Inc.2012-03-01
Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflat recall (Z-0559-06)Acclarent Inc2006-02-24

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Every clearance here is in the API, with alerts when new ones post.