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ArthroCare Corporation

USA · Austin

✓ 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

47listed device types

Class I 28Class II 19Class III 0

plus 228 registration records and 149 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

25registered devices

Class I 11Class II 14

34 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

56active device licences

Class II 24Class III 32

75 including historic records

TWTaiwanTFDA

42valid device licences

Class I 14Class II 28

SGSingaporeHSA SMDR

26device registrations

CLASS B 4CLASS C 21CLASS D 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

27active ARTG entries

Class I 6Class III 1IIa 8IIb 10Class Is (sterile) 2

HKHong KongMDACS

11valid listings

Class II 4Class III 6Class IV 1

ILIsraelAMAR

23registrations

RURussiaRoszdravnadzor

17active registrations

Class 1 1Class 2a 6Class 2b 8Class 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 States228 registration records, 149 510(k), 0 PMA

Brazil25 confirmed, 0 excluded

Canada56 confirmed, 0 excluded

Manufacturer names merged into this page: ArthroCare Corporation · Arthrocare Corporation · ARTHROCARE CORPORATION

FDA 510(k) clearances by year

82006

112007

92008

82009

82010

62011

22012

92013

62014

42015

52016

22017

12018

22019

12020

12021

12022

22023

12024

22026

FDA listed device types

showing 8 of 47

Electrosurgical, Cutting & Coagulation & Accessories 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Fastener, Fixation, Biodegradable, Soft Tissue 1Pin, Fixation, Smooth 1Negative Pressure Wound Therapy Device For Reduction Of Wound Complications 1Fastener, Fixation, Nondegradable, Soft Tissue 1Filler, Bone Void, Calcium Compound 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254122	FLOW FLEXTEND Wand (72290039)	2026-03-30
US	K253680	LYNX COBLATION Laryngeal Wand (72290254)	2026-03-25
US	K240964	FLOW 90? Wand	2024-05-08
BR	80804050267	Rapid Pac Dispositivo de Epistaxe	Class II
BR	80804050221	Instrumental Articulado Cortante Estéril Descartável Arthrocare	Class I
BR	80804050238	PASSADOR DE SUTURA ACCU-PASS DIRECT	Class II
CA	76463	SPEEDSTITCH SUTURING DEVICES	Class III
CA	89665	SPEEDLOCK KNOTLESS FIXATION DEVICE	Class III
CA	91334	ARTHROCARE OBTURATORS	Class II