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ATRICURE, INC.

USA · Mason

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

20listed device types

Class I 8Class II 11Class III 1

plus 67 registration records and 59 510(k), 35 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 7Class IV 2

19 including historic records

TWTaiwanTFDA

20valid device licences

Class I 1Class II 18Class III 1

SGSingaporeHSA SMDR

5device registrations

CLASS C 1CLASS D 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

31active ARTG entries

Class I 3Class III 21IIa 2IIb 4Class Is (sterile) 1

HKHong KongMDACS

7valid listings

Class III 2Class IV 5

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States67 registration records, 59 510(k), 35 PMA, 1 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: ATRICURE, INC. · AtriCure, Inc. · ATRICURE, INC

Business registration

CIK: 0001323885
Registration status: Active
Listing status: Listed (ATRC)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12006

22007

12008

12009

32010

42011

32012

22013

42014

12015

32016

42017

62018

52019

12020

32021

12022

22023

42024

32025

FDA listed device types

showing 8 of 20

Instrument, Ligature Passing And Knot Tying 1Cannula, Surgical, General & Plastic Surgery 1Dissector, Surgical, General & Plastic Surgery 1Instrument, Manual, Surgical, General Use 1Cutter, Surgical 1Stand, Instrument, Ac-Powered, Ophthalmic 1Instruments, Surgical, Cardiovascular 1Guide, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252056	Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)	2025-07-24
US	K250371	cryoICE cryoXT cryoablation probe (cryoXT)	2025-04-10
US	K243860	AtriClip PRO-Mini LAA Exclusion System (PROM)	2025-01-15
CA	9535	COBRA ELECTROSURGICAL SYSTEM	Class IV
CA	60877	COBRA COOLED SURGICAL PROBE	Class II
CA	64748	COBRA BIPOLAR SYSTEM	Class II