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ETHICON, LLC.

USA · Norderstedt

✓ 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

53listed device types

Class I 16Class II 32Class III 4unclassified 1

plus 344 registration records and 208 510(k), 448 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 1Class II 12

80 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 4Class III 4Class IV 1

122 including historic records

TWTaiwanTFDA

29valid device licences

Class II 23Class III 6

SGSingaporeHSA SMDR

45device registrations

CLASS B 2CLASS C 11CLASS D 32

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

56active ARTG entries

Class I 3Class III 44IIa 5IIb 4

HKHong KongMDACS

48valid listings

Class II 3Class III 8Class IV 37

ILIsraelAMAR

32registrations

RURussiaRoszdravnadzor

20active registrations

Class 2a 3Class 2b 4Class 3 13

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 States344 registration records, 208 510(k), 448 PMA, 14 excluded

Brazil13 confirmed, 11 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada9 confirmed, 4 excluded

Manufacturer names merged into this page: ETHICON, LLC. · ETHICON, INC. · ETHICON, LLC · ETHICON SARL · ETHICON GMBH · ETHICON INC.

FDA 510(k) clearances by year

22004

42005

62006

32007

22008

72010

22011

12012

42013

52014

52015

22016

42017

82018

42019

42020

12021

22022

22025

42026

FDA listed device types

showing 8 of 53

Electrosurgical, Cutting & Coagulation & Accessories 1Fibrin Sealant Preparation Device 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Screw, Fixation, Bone 1Clip, Implantable 1Staple, Implantable 1Laparoscope, General & Plastic Surgery 1System, Ablation, Microwave And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253394	Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture	2026-06-25
US	K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices	2026-05-18
US	K253572	STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device	2026-03-27
BR	10132590023	FITA CARDÍACA	Class II
BR	80145909087	Aplicador Endoscópico SURGICEL	Class II
BR	10132590602	SISTEMA DE DRENAGEM J-VAC*	Class II
CA	14056	TEFLON PASTE	Class III
CA	600	VERSAPOINT HYSTEROSCOPIC ELECTRODES	Class II
CA	622	VERSAPOINT II HYSTEROSCOPIC ELECTROSURGICAL GENERATOR	Class III