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Acclarent, Inc.

45 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Acclarent AERA Eustachian Tube Balloon Dilation System (K253612)Acclarent, Inc.2026-02-19
ACCLARENT AERA Eustachian Tube Dilation System (K230742)Acclarent, Inc.2023-12-13
TruDi® Navigation System V3 (FG-2000-00) (K231862)Acclarent, Inc.2023-07-21
TruDi Shaver Blade (K221037)Acclarent, Inc.2022-07-20
Next Generation Balloon Dilation System (K201115)Acclarent, Inc.2020-08-27
TruDi Curette (K201174)Acclarent, Inc.2020-08-12
TruDi Probe (K193453)Acclarent, Inc.2020-03-23
RELIEVA ULTIRRA Sinus Balloon Catheter (K190525)Acclarent, Inc.2019-05-03
TruDi NAV Wire (K190532)Acclarent, Inc.2019-05-03
Relieva Tract Balloon Dilation System (K183090)Acclarent, Inc.2019-04-19
TruDi NAV Suction Instruments (K180948)Acclarent, Inc.2018-07-20
Acclarent ENT Navigation System (K173628)Acclarent, Inc.2018-03-10
ACCLARENT AERA Eustachian Tube Balloon Dilation System (K171761)Acclarent, Inc.2018-01-16
Relieva SpinPlus Nav Balloon Sinuplasty System (K171687)Acclarent, Inc.2017-09-05
Relieva UltirraNav Sinus Balloon Catheter (K161698)Acclarent, Inc.2016-10-24
Acclarent NavWire Sinus Navigation Guidewire (K161697)Acclarent, Inc.2016-10-24
Acclarent Aera Eustachian Tube Balloon Dilation System (DEN150056)Acclarent, Inc.2016-09-16
Relieva Scout Multi-Sinus Dilation System (K153341)Acclarent, Inc.2016-02-12
TULA Iontophoresis System with Earset (K150453)Acclarent, Inc.2015-05-20
Relieva SpinPlus Balloon Sinuplasty System (K143541)Acclarent, Inc.2015-04-22
ACCLARENT SE Inflation Device (K150172)Acclarent, Inc.2015-04-07
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K132433)Acclarent, Inc.2014-04-24
RELIEVA SCOUT SINUS DILATION SYSTEM (K140160)Acclarent, Inc.2014-02-20
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM (K120280)Acclarent, Inc.2012-11-05
RELIEVA SPIN SINUS DILATION SYSTEM (K111875)Acclarent, Inc.2011-10-11
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (K110687)Acclarent, Inc.2011-10-07
RELIEVA SOLO ELITE SINUS BALLOON CATHETER (K111254)Acclarent, Inc.2011-08-22
TULA IONTOPHORESIS SYSTEM (K110636)Acclarent, Inc.2011-06-16
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K110097)Acclarent, Inc.2011-05-27
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM (K103595)Acclarent, Inc.2011-04-01
INSPIRA AIR BALLOON DILATION SYSTEM (K110218)Acclarent, Inc.2011-03-31
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE (K100577)Acclarent, Inc.2011-01-06
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (K093594)Acclarent, Inc.2010-03-03
AIRWAY BALLOON CATHETER INFLATION DEVICE (K090660)Acclarent, Inc.2009-06-12
RELIEVA STRATUS MICROFLOW SPACER (K083574)Acclarent, Inc.2009-01-29
TYMPANOSTOMY TUBE (K082188)Acclarent, Inc.2008-09-19
SINUS SPACER (K072891)Acclarent, Inc.2008-03-19
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (K073041)Acclarent, Inc.2008-03-11
IONTOPHORESIS SYSTEM (K073276)Acclarent, Inc.2008-03-05
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (K071845)Acclarent, Inc.2007-09-28
MICROENDOSCOPE (K063078)Acclarent, Inc.2006-10-24
ETHMOID SINUS SPACER (K062458)Acclarent, Inc.2006-09-15
RELIEVA SINUS BALLOON CATHETER (K061903)Acclarent, Inc.2006-08-18
RELIENT NAVIGATION DEVICE (K060974)Acclarent, Inc.2006-05-05
RELIEVA SINUS BALLOON INFLATION DEVICE (K052198)Acclarent, Inc.2005-08-31

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