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ETHICON ENDO-SURGERY, INC.

USA · Cincinnati

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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 7Class II 12Class III 0unclassified 1

plus 236 registration records and 193 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 3Class II 25

80 including historic records

SASaudi ArabiaSFDA

6registered imported devices

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

CACanadaMDALL

15active device licences

Class II 10Class III 5

79 including historic records

TWTaiwanTFDA

42valid device licences

Class I 4Class II 38

SGSingaporeHSA SMDR

52device registrations

CLASS B 18CLASS C 24CLASS D 10

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

62active ARTG entries

Class I 15Class III 18IIa 12IIb 16Class Is (sterile) 1

HKHong KongMDACS

44valid listings

Class II 7Class III 26Class IV 11

ILIsraelAMAR

31registrations

RURussiaRoszdravnadzor

36active registrations

Class 1 4Class 2a 7Class 2b 19Class 3 6

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 States236 registration records, 193 510(k), 0 PMA, 11 excluded

Brazil28 confirmed, 8 excluded

Saudi Arabia6 confirmed, 3 excluded

Canada15 confirmed, 6 excluded

Manufacturer names merged into this page: ETHICON ENDO-SURGERY, LLC · ETHICON ENDO-SURGERY, INC. · ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II · ETHICON ENDO-SURGERY INC. · ETHICON ENDO-SURGERY LLC · ETHICON ENDO-SURGERY INC SA DE CV - MEXICO PARA ETHICON ENDO-SURGERY INC

Same-named companies — This database also contains companies with near-identical names: Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company), ETHICON ENDO-SURGERY INC SA DE CV - MEXICO PARA ETHICON ENDO-SURGERY INC, ETHICON ENDO-SURGERY, S.A DE C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

62007

72008

72009

62010

92011

62012

92013

32014

32015

52016

42017

42018

22019

62020

32021

22022

42023

22024

42025

22026

FDA listed device types

showing 8 of 20

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Tissue Approximation Device 1Electrocautery, Gynecologic (And Accessories) 1Apparatus, Pneumoperitoneum, Automatic 1Laparoscopic Accessories, Esophageal Sizing 1Mesh, Surgical, Absorbable, Staple Line Reinforcement 1Apparatus, Exhaust, Surgical 1Stapler, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260196	ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)	2026-05-11
US	K252906	ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)	2026-01-09
US	K252739	ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)	2025-12-17
BR	10132590043	TROCARTE CIRURGICO ENDOPATH	Class II
BR	10132590060	TROCARTE CIRURGICO FLEXIVEL FLEXIPATH*	Class II
BR	80145900744	TROCARTES CIRÚRGICOS ENDOPATH XCEL	Class II
SA	ME0000003220SFDAA00064	LIGACLIP® Clip Applier	—
SA	ME0000003220SFDAA00060	LIGACLIP® Clip Applier Cartridge Base	—
CA	4082	PROXIMATE SKIN STAPLER	Class II
CA	10686	MAMMOTOME BIOPSY SYSTEM	Class II
CA	66536	MOMMOTOME EX HAND-HELD SYSTEM	Class II

ETHICON ENDO-SURGERY, 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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