Acclarent Inc

FDA Filings

This page includes the latest FDA filings for Acclarent Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005172759
FEI Number3005172759
NameACCLARENT, INC.
Owner & OperatorACCLARENT, INC.
Contact Address33 TECHNOLOGY DRIVE --
Irvine CA 92618 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address31 Technology Dr Suite 200
Irvine, CA 92618 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
ACCLARENT, INC.
TruDi Curette TDC0005Z2020-09-08
ACCLARENT, INC.
TruDi Curette TDC00052020-09-08
Acclarent Inc.
Next Generation Balloon Dilation System2020-08-27
Acclarent, Inc.
TruDi Curette2020-08-12
ACCLARENT, INC.
TruDi Probe TDP0705Z2020-08-10
ACCLARENT, INC.
TruDi Probe TDP0005Z2020-08-10
ACCLARENT, INC.
TruDi Probe TDP07052020-08-10
ACCLARENT, INC.
TruDi Probe TDP00052020-08-10
ACCLARENT, INC.
ACCLARENT SE INFLATION DEVICE SEID2020-05-06
ACCLARENT, INC.
ACCLARENT BALLOON INFLATION DEVICE BID302020-05-06
ACCLARENT, INC.
ACCLARENT SE INFLATION DEVICE SEID2020-05-06
Acclarent, Inc.
TruDi Probe2020-03-23
ACCLARENT, INC.
TruDi NAV Suction TDNS090Z2020-01-22
ACCLARENT, INC.
TruDi NAV Suction TDNS070Z2020-01-22
ACCLARENT, INC.
TruDi NAV Suction TDNS000Z2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1640AZ2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1640A2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1440AZ2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1440A2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1240AZ2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1240A2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1040AZ2020-01-22
ACCLARENT, INC.
RELIEVA TRACT RT1040A2020-01-22
ACCLARENT, INC.
TruDi NAVWIRE TDNW001Z2020-01-22
ACCLARENT, INC.
TruDi NAVWIRE TDNW0012020-01-22
ACCLARENT, INC.
TruDi NAV Cable TDNC0012020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS NAV RSP0616MFSN2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS NAV RSP0516MFSN2020-01-22
ACCLARENT, INC.
RELIEVA ULTIRRA NAV BC0516RUN2020-01-22
ACCLARENT, INC.
RELIEVA SCOUT SCT0624MFS2020-01-22
ACCLARENT, INC.
ACCLARENT NAVWIRE GW35150NZ2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP06162020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP05162020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0616M2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0616F2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0516M2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0516F2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0516FZ2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0516MFS2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0516MFSZ2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0616MFSZ2020-01-22
ACCLARENT, INC.
RELIEVA SPINPLUS RSP0616MFS2020-01-22
ACCLARENT, INC.
RELIEVA CIRCA EP012020-01-22
ACCLARENT, INC.
ACCLARENT AERA EU0616552020-01-22
ACCLARENT, INC.
ACCLARENT AERA EU061655Z2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0616MFS2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0616MFSZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0516MFS2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0516MFSZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSM110CZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSM110C2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0516FZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0516MZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0516M2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0516F2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC8524A2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSM110Z2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSM1102020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSS02020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSS0Z2020-01-22
ACCLARENT, INC.
RELIEVA VORTEX 2 RV02Z2020-01-22
ACCLARENT, INC.
RELIEVA VORTEX 2 RV022020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSF702020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0616MZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0616M2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0616F2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RS0616FZ2020-01-22
ACCLARENT, INC.
RELIEVA SPIN RSF70Z2020-01-22
ACCLARENT, INC.
RELIEVA ULTIRRA BC0724RU2020-01-22
ACCLARENT, INC.
RELIEVA ULTIRRA BC0716RU2020-01-22
ACCLARENT, INC.
RELIEVA ULTIRRA BC0616RU2020-01-22
ACCLARENT, INC.
RELIEVA ULTIRRA BC0516RU2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1640A2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1240A2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1640AZ2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1240AZ2020-01-22
ACCLARENT, INC.
RELIEVA LUMA SISLGC2082020-01-22
ACCLARENT, INC.
RELIEVA LUMA SENTRY SIS100BZ2020-01-22
ACCLARENT, INC.
RELIEVA LUMA SENTRY SIS100B2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC0724A2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC0524A2020-01-22
ACCLARENT, INC.
RELIEVA SIDEKICK LP SDKKLPZ2020-01-22
ACCLARENT, INC.
RELIEVA SIDEKICK LP SDKKLP2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC110RF2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC090RF2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC070CRF2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC000RF2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1440A2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1040A2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC110RFZ2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC090RFZ2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC070CRFZ2020-01-22
ACCLARENT, INC.
RELIEVA FLEX GC000RFZ2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1440AZ2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC1040AZ2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC0724AZ2020-01-22
ACCLARENT, INC.
INSPIRA AIR BC0524AZ2020-01-22
ACCLARENT, INC.
RELIEVA LUMA SISLGCASTORZ2020-01-22
ACCLARENT, INC.
RELIEVA LUMA SISLGCAOLYMP2020-01-22
ACCLARENT, INC.
ACCLARENT CYCLOPS CYE002R2020-01-22
ACCLARENT, INC.
ACCLARENT CYCLOPS CYE0022020-01-22
ACCLARENT, INC.
RELIEVA LUMA SISLGCAWOLF2020-01-22
ACCLARENT, INC.
RELIEVA LUMA SISLGCAACMI2020-01-22
ACCLARENT, INC.
Relieva Ultirra Sinus Balloon Catheter2019-08-26
ACCLARENT, INC.
TruDi NAVWIRE2019-05-08
Acclarent, Inc.
TruDi NAV Wire2019-05-03
Acclarent, Inc.
RELIEVA ULTIRRA Sinus Balloon Catheter2019-05-03
ACCLARENT, INC.
Relieva Tract Balloon Dilation System2019-04-25
Acclarent, Inc.
Relieva Tract Balloon Dilation System2019-04-19
ACCLARENT, INC.
TruDi NAV Suction2018-10-09
ACCLARENT, INC.
TruDi NAV Cable2018-10-09
Acclarent, Inc.
TruDi NAV Suction Instruments2018-07-20
Acclarent, Inc
Acclarent ENT Navigation System2018-03-10
ACCLARENT, INC.
Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System2018-01-26
ACCLARENT, INC.
Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System2018-01-26
Acclarent, Inc.
ACCLARENT AERA Eustachian Tube Balloon Dilation System2018-01-16
Acclarent, Inc.
Relieva SpinPlus Nav Balloon Sinuplasty System2017-09-05
ACCLARENT, INC.
Acclarent Relieva Ultirra? Nav Sinus Balloon Catheter2016-11-15
ACCLARENT, INC.
Acclarent Navwire Sinus Navigation Guidewire2016-11-15
ACCLARENT, INC.
Relieva UltirraNav Sinus Balloon Catheter2016-10-24
ACCLARENT, INC.
Acclarent NavWire Sinus Navigation Guidewire2016-10-24
ACCLARENT, INC.
Acclarent Aera Eustachian Tube Balloon Dilation System2016-09-16
ACCLARENT, INC.
Acclarent AERA Eustachian Tube Balloon Dilation System2016-09-16
ACCLARENT, INC.
Scout? Multi-Sinus Dilation System2016-03-08
ACCLARENT, INC.
Relieva Scout Multi-Sinus Dilation System2016-02-12
ACCLARENT, INC.
Relieva SpinPlus Balloon Sinuplasty System2015-12-14
ACCLARENT, INC.
Relieva Circa Ethmoid Punch2015-09-16
ACCLARENT, INC.
ACCLARENT SE Inflation Device2015-06-09
ACCLARENT, INC.
TULA Iontophoresis System With Earset2015-05-20
ACCLARENT, INC.
Relieva SpinPlus Balloon Sinuplasty System2015-04-22
ACCLARENT, INC.
ACCLARENT SE Inflation Device2015-04-07
ACCLARENT, INC.
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE2014-04-24
ACCLARENT, INC.
RELIEVA SCOUT SINUS DILATION SYSTEM2014-02-20
ACCLARENT, INC.
Relieva Vortex 22013-10-30
ACCLARENT, INC.
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM2012-11-05
ACCLARENT, INC.
Relieva Luma Light Guide Cable 22012-01-18
ACCLARENT, INC.
Light Guide Cable Adapters2012-01-18
ACCLARENT, INC.
Relieva Spin Balloon Sinuplasty System2012-01-13
ACCLARENT, INC.
Relieva Ultirra Sinus Balloon Catheter2012-01-13
ACCLARENT, INC.
Cyclops Multi-Angle Endoscope2012-01-13
ACCLARENT, INC.
Relieva Luma Sentry Sinus Illumination System2012-01-13
ACCLARENT, INC.
Relieva Sidekick LP2012-01-13
ACCLARENT, INC.
Relieva Flex Guide Catheter2012-01-13
ACCLARENT, INC.
RELIEVA SPIN SINUS DILATION SYSTEM2011-10-11
ACCLARENT, INC.
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)2011-10-07
ACCLARENT, INC.
RELIEVA SOLO ELITE SINUS BALLOON CATHETER2011-08-22
ACCLARENT, INC.
TULA IONTOPHORESIS SYSTEM2011-06-16
ACCLARENT, INC.
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE2011-05-27
ACCLARENT, INC.
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM2011-04-01
ACCLARENT, INC.
INSPIRA AIR BALLOON DILATION SYSTEM2011-03-31
ACCLARENT, INC.
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE2011-01-06
ACCLARENT, INC.
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER2010-03-03
ACCLARENT, INC.
Inspira Air Balloon Dilation System2009-07-29
ACCLARENT, INC.
AIRWAY BALLOON CATHETER INFLATION DEVICE2009-06-12
ACCLARENT, INC.
TYMPANOSTOMY TUBE2008-09-19
ACCLARENT, INC.
SINUS SPACER2008-03-19
ACCLARENT, INC.
IONTOPHORESIS SYSTEM2008-03-05
ACCLARENT, INC.
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A2007-09-28
ACCLARENT, INC.
MICROENDOSCOPE2006-10-24
ACCLARENT, INC.
RELIEVA SINUS BALLOON CATHETER2006-08-18
ACCLARENT, INC.
RELIEVA SINUS BALLOON INFLATION DEVICE2005-08-31
ACCLARENT, INC.
Acclarent Inflation Device2005-05-20

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