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ACCLARENT, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, Russia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 6Class II 4Class III 0

plus 25 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

10active device licences

Class II 10

18 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States25 registration records, 45 510(k), 0 PMA

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: ACCLARENT, INC. · ACCLARENT INC.

FDA 510(k) clearances by year

12005

42006

12007

42008

22009

12010

82011

12012

22014

32015

42016

12017

32018

32019

32020

12022

22023

12026

FDA listed device types

showing 8 of 10

Ear, Nose, And Throat Stereotaxic Instrument 1Eustachian Tube Balloon Dilation Device 1Bronchoscope Accessory 1Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Instrument, Ent Manual Surgical 1Punch, Ethmoid 1Cannula, Sinus 1Source, Carrier, Fiberoptic Light 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253612	Acclarent AERA Eustachian Tube Balloon Dilation System	2026-02-19
US	K230742	ACCLARENT AERA Eustachian Tube Dilation System	2023-12-13
US	K231862	TruDi® Navigation System V3 (FG-2000-00)	2023-07-21
CA	75467	RELIEVA BALLOON SINUPLASTY SYSTEM	Class II
CA	78764	RELIEVA SOLO PRO SINUS BALLOON CATHETER	Class II
CA	83771	RELIEVA FLEX SINUS GUIDE CATHETER	Class II

ACCLARENT, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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